FDA Registration
Active
🇺🇸 United States
VIVE Health LLC
Reg #: 3011191255
·
FEI: 3011191255
·
Expires 2026
Products
113
Proprietary Names
773
Establishment Types
3
Classifications
113
Registration Details
- Registration Name
- VIVE Health LLC
- Registration Number
- 3011191255
- FEI Number
- 3011191255
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 8955 Fontana Del Sol Way
- City
- Naples
- State
- FL
- ZIP
- 34109
- Country
- US
Regulatory Submissions
- 510(k) Number
- K251159
Owner / Operator
- Firm Name
- VIVE Health LLC
- Operator Number
- 10047487
- Address
- 8955 Fontana Del Sol Way
- City
- Naples
- State
- FL
- Postal Code
- 34109
- Country
- US
- Correspondent
- Joseph Fleming
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wheelchair, Powered | ITI | Class 2 | Physical Medicine | No | 2026-03-20 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2025-12-23 |
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2026-03-16 |
| Vehicle, Motorized 3-Wheeled | INI | Class 2 | Physical Medicine | No | 2026-03-20 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2022-11-16 |
| Adaptor, Dressing | ILD | Class 1 | Physical Medicine | No | 2025-07-28 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2025-11-21 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2025-07-28 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2018-10-05 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2018-10-05 |
| Armrest, Wheelchair | IML | Class 1 | Physical Medicine | No | 2025-08-11 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2026-03-12 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2026-03-16 |
| Orthosis, Foot Drop | OHI | Class 1 | Physical Medicine | No | 2025-07-16 |
| Protector, Ostomy | EXE | Class 1 | Gastroenterology, Urology | No | 2026-03-04 |
| Brake, Extension, Wheelchair | IMW | Class 1 | Physical Medicine | No | 2026-03-20 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2019-12-19 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2025-07-16 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2025-12-01 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2025-07-28 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2026-03-05 |
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2026-03-05 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2026-03-12 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2025-11-21 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2025-05-13 |
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2025-07-07 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2026-03-12 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2025-07-28 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2018-10-05 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2022-11-09 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2022-11-09 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2022-11-09 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2026-03-19 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2026-03-19 |
| Attachment, Commode, Wheelchair | INB | Class 1 | Physical Medicine | No | 2025-07-16 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2025-08-11 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2026-03-05 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2017-10-05 |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | Class 2 | General Hospital | No | 2019-12-19 |
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2025-07-16 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2026-03-05 |
| Chair, Positioning, Electric | INO | Class 2 | Physical Medicine | No | 2019-12-19 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2025-05-13 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2026-03-12 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2026-03-12 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2025-07-16 |
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 2018-10-05 |
| Components, Exercise | IOD | Class 1 | Physical Medicine | No | 2026-02-25 |
| Stocking, Elastic | ILG | Class 1 | Physical Medicine | No | 2026-03-12 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2026-03-23 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2026-03-12 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2026-03-12 |
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 2026-03-19 |
| Footrest, Wheelchair | IMM | Class 1 | Physical Medicine | No | 2025-08-11 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2026-03-11 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2026-03-17 |
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2026-05-06 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2018-05-22 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2025-05-13 |
| Adaptor, Grooming | ILW | Class 1 | Physical Medicine | No | 2026-03-20 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2026-03-17 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2025-08-13 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2025-12-01 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2025-07-14 |
| Suprapubic Catheter Accessories | QGC | Class 1 | Gastroenterology, Urology | No | 2026-03-05 |
| Cane | IPS | Class 1 | Physical Medicine | No | 2025-05-13 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2025-07-28 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2026-03-12 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2026-03-12 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2026-06-18 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2022-11-09 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2025-07-28 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2019-12-19 |
| Cover, Cast | KIA | Class 1 | General Hospital | No | 2026-03-11 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2026-03-12 |
| Chair, With Casters | INM | Class 1 | Physical Medicine | No | 2026-03-05 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2025-12-01 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2026-03-12 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2022-11-09 |
| Utensil, Eating | ILC | Class 1 | Physical Medicine | No | 2025-12-05 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2024-08-28 |
| Device, Patient Transfer, Powered | FRZ | Class 2 | General Hospital | No | 2026-03-05 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2026-03-12 |
| Bedpan | FOB | Class 1 | General Hospital | No | 2025-08-13 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2026-03-12 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2025-03-19 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2025-09-05 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2018-05-22 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2026-03-05 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2026-03-05 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2026-03-05 |
| Binder, Medical, Therapeutic | MDR | Class 1 | General Hospital | No | 2026-03-12 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2025-07-28 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2025-07-14 |
| Lift, Patient, Ac-Powered | FNG | Class 2 | General Hospital | No | 2026-03-05 |
| Sling, Arm, Overhead Supported | ILE | Class 1 | Physical Medicine | No | 2022-11-09 |
| Helmet, Cranial, For Protective Use | NDA | Class 1 | Physical Medicine | No | 2026-03-05 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | No | 2025-05-13 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-07-07 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2025-08-13 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2026-03-12 |
| Table, Mechanical | INW | Class 1 | Physical Medicine | No | 2025-07-28 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2026-03-12 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2025-07-14 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2026-03-12 |
| Restraint, Protective | FMQ | Class 1 | General Hospital | No | 2025-08-13 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2018-10-05 |
| Analyzer, Body Composition | MNW | Class 2 | Cardiovascular | No | 2019-12-19 |
| Bag, Drainage, With Adhesive, Ostomy | FON | Class 1 | Gastroenterology, Urology | No | 2025-07-16 |
| Tips And Pads, Cane, Crutch And Walker | INP | Class 1 | Physical Medicine | No | 2025-07-14 |
| Scale, Stand-On, Patient | FRI | Class 1 | General Hospital | No | 2019-08-26 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2025-12-01 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2026-03-05 |
Proprietary Names
Power Wheelchair Model C
Power Wheelchair
FloTilt Power Wheelchair MOB1138
Sterno-Costal Orthosis
456 TLSO
Rib Brace
464 TLSO
C.A.S.H Orthosis
Sport Wheelchair
Mobility Scooter Series A MOB1053
Arch Supports
Walker Boot Air Pro (Short)
1930 AFO
Bunion Splint
Ankle Wraps
4386 Short Walker Boot
Ankle Sleeves with Straps
Walker Boot Air Pro (Tall)
Arm Protection Sleeves
Walker Boot Pro (Tall)
Ankle Air Stabilizer
Anterior Carbon Fiber AFO
Quick Lace Ankle Brace
350 Ankle Air Splint
4386 Standard Walker Boot
ROM Walking Boot
Felt Arch Pads
Dorsal Night Splint
Laced Ankle Brace
Exo Walker Boot
Achilles Wedge
971 Ankle Brace
386 Walker Boot
Air Ankle Splint
Heel Pillows
Ankle Air Splint
Motion Ankle Brace
Pneumatic Walking Boot
Walker Boot Pro (Short)
Air CAM Walker Boot
1906 Motion Ankle Brace
Air Stirrup Ankle Brace
CAM Walker Boot
360 Walker Boot
Hip and Knee Recovery Kit
Sock Removal Aid
Dressing Stick
Sock Assist and Remover
Shoe Remover
Sock Assist
Bendable Sock Asssit
Button Hook
TeleRPM Pulse Oximeter 4G
Cold Massage Roller Ball
Sensory Rings
Compact BPM
Heating Pads
Extending Wheelchair Arm Rests
Height Adjustable Wheelchair Arm Rests
ROM Hip Brace
Blood Glucose Test Strips
Blood Glucose Monitor DMD1079
Individual Toe Caps
Hammer Toe Splint
Plantar Fasciitis Stretch Splint
Toe Wrap
Toe Pouches
Bunion Protector
3 Layer Toe Separators
Toe Sleeves
Dual Calf Stretcher
Toe Spacers
Toe Separators
Bunion Kit
Ergonomic Toe Separators
Little Toe Sleeves
Gel Bunion Sleeve
Gel Metatarsal Sleeves
Gel Heel Protectors
Ostomy Support Belt
Ostomy Adhesive Barrier Ring
Ostomy Adhesive Barrier
Ostomy Bag Clamps
Ostomy Adhesive Barrier Strip
Leg Rest Heel Loop
Brake Handle Extensions
DMD1013 Sphygmomanometer
Triple Toe Splint
Double Toe Splint
Silicone Heel Cups
U Shaped Felt Callus Pads
Toe Splint
Ostomy Scissors
Rise Up Toilet Rail
Bariatric Commode
Folding Commode
Folding Shower Chair
Compact Toilet Rail
Stand Alone Toilet Rail
Easy Rinse Shower Chair
Sliding Shower Chair
Toilet Safety Frame with Handles
Bed Rail
Toilet Safety Rail
Transfer Bench
Shower Chair Toilet Riser
Shower Chair
Toilet Safety Frame
Stand Assist
Height Adjustable Bed Rail
Bathtub Rail
Shower Commode Transport Chair
Bariatric Shower Chair
Crutches
Forearm Crutches
Portable Oxygen Concentrator LVA3117
Portable Oxygen Concentrator Juniper AC Adapter
Portable Oxygen Concentrator Juniper External Battery Charger
Portable Oxygen Concentrator Juniper Nasal Cannula
Portable Oxygen Concentrator Juniper Filters
Portable Oxygen Concentrator Juniper DC Charger
Portable Oxygen Concentrator Juniper Carry Bag
Portable Oxygen Concentrator Juniper Sieve Bed
Portable Oxygen Concentrator Juniper Battery
Portable Oxygen Concentrator Juniper AC Power Cord
Elbow Compression Sleeve
Waist High Compression Pantyhose 15-20mmHg
Knee High Anti Embolism Stockings 15-20mmHg
Compression Wrist Wrap
Knee Sleeves
Thigh High Anti Embolism Stockings 15-20mmHg
Knee High Compression Stockings 15-20mmHg
Leg Compression Sleeve
Multi Purpose Support Wraps
Finger Sleeves
Thigh High Open Toe Compression Stockings 15-20mmHg
Wrist Compression Sleeve
Knee High Compression Stockings 20-30mmHg
Calf Compression Sleeve
Arm Compression Sleeve
Compression Knee Sleeve
Thigh High Compression Stockings 15-20mmHg
Knee Brace Undersleeve
Thigh Compression Sleeve
Blood Pressure Monitor Smart Phone Compatible DMD1092 DMD1094
Wound Cleanser
Gel Thumb Support
Palm Protector with Finger Separators
Resting Hand Splint
Finger Splint
807 Thumb Splint
Dual Finger Splint
Finger Grip Brace
Dual Trigger Finger Splint
Advanced Wrist Brace
Wrist Wraps
Overnight Wrist Brace
Boxer Splint
Extended Trigger Finger Splint
Trigger Finger Splint
Quick Lace Wrist Brace
Thumb Brace
908 Wrist Splint
Standard Thumb Brace
Quick Lace Thumb Brace
Trigger Finger Splint Brace
Palm Protectors
Tunnel Tamer
Thumb Spica
Carbon Crossover Power Wheelchair MOB1123
Copper Full Finger Arthritis Gloves
Arthritis Gloves with Grips
Arthritis Gloves
Full Finger Arthritis Gloves
Copper Arthritis Gloves Fingerless
CPAP Hose
Oral Thermometer
RHB1043 Tens Digital Massager
3-Wheel Scooter MOB1025
Easy Twist Lancets
Toilet Seat Riser
Padded Commode
Toilet Seat Riser with Arms
Reclining Shower Commode Transport Chair
Bariatric 4-in-1 Commode and Shower Chair
Raised Toilet Seat
CoreTech Compression System (RHB3003)
Denture Cleaning Tablets
Blood Pressure Monitor DMD1001
Tens Unit Replacement Patch
Zippered Knee High Compression Stockings 15-20mmHg
Knee High Compression Stockings 30-40mmHg
Knee High Men's Compression Dress Socks 15-20mmHg
Knee High Compression Stockings
Thigh High Compression Stockings 20-30mmHg
Zippered Knee High Compression Stockings 20-30mmHg
Sports Compression Socks
Waist High Compression Pantyhose 20-30mmHg
Knee High Open Toe Compression Stockings 20-30mmHg
Knee High Men's Compression Dress Socks 20-30mmHg
Knee High Open Toe Compression Stockings 15-20mmHg
MOB1030 Folding Mobility Scooter
MOB1027 4-Wheel Mobility Scooter
MOB1053 Mobility Scooter - Series A
MOB1025 3-Wheel Mobility Scooter
Pediatric Wheelchair MOB1145
Reclining Pediatric Wheelchair MOB1146
Heel Lift Inserts
Arch Support Sheepskin Insoles
Heel Cups
Shock Absorbing Heel Cup
Heavy Duty Gel Insoles
Carbon Fiber Insoles
Heavy Duty Insoles
Arch Support Gel Insoles
Memory Foam Insoles
High Heels Insoles
Wrist BPM DMD1063
3 Wheel Mobility Scooter
4 Wheel Mobility Scooter MOB1137
Mobility Scooter
MOB1029L Large Power Wheelchair
MOB1054 Electric Wheelchair Model: V
MOB1029S Small Power Wheelchair
Pediatric Compressor Nebulizer (Bear)
Lift Chair
Handheld Massager
Adhesive Remover Wipes
AirCarbon Power Wheelchair MOB1140
Oral Thermometer Large Display
Moist Heat Pack
Comfort+ Nasal CPAP Mask Frame
Comfort+ Full Face CPAP Mask Headgear
Classic Nasal Pillows CPAP Mask Headgear
Comfort+ Full Face CPAP Mask Headgear with Clip
Comfort+ CPAP Mask Soft Sleeves
Fit Packs
Oxygen Concentrator Port
CPAP Mask Clips
Classic Nasal CPAP Mask Frame
Classic Full Face CPAP Mask Frame
Comfort+ Full Face CPAP Mask Cushion
Comfort+ Full Face CPAP Mask Frame
Classic Nasal CPAP Mask
Classic Full Face CPAP Mask
Comfort+ Nasal CPAP Mask
Classic Nasal Pillows CPAP Mask Frame
Comfort+ Nasal CPAP Mask Headgear with Clip
Classic Nasal CPAP Mask Headgear with Clip
Classic Nasal Pillows CPAP Mask Cushion
Comfort+ Nasal CPAP Mask Cushion
Comfort+ Nasal CPAP Mask Tubing 18
CPAP Mask Swivel
Comfort+ Nasal CPAP Mask Headgear
Classic Full Face CPAP Mask Headgear with Clip
Classic Nasal CPAP Mask Headgear
Comfort+ Full Face CPAP Mask
Classic Full Face CPAP Mask Headgear
Classic Full Face CPAP Mask Cushion
Classic Nasal Pillows CPAP Mask
Classic Nasal Pillows CPAP Mask Headgear with Clip
Classic Nasal CPAP Mask Cushion
Tube Alternating Pressure Pad
5" Alternating Pressure Pad
Full Alternating Pressure Pad System
Alternating Pressure Seat Pad
Alternating Pressure Pad
Standard Alternating Pressure Pad
Alternating Pressure Pad Replacement
Low Air Loss Mattress 8"
Low Air Loss Alternating Pressure Mattress Lateral Rotation 8"
Low Air Loss Alternating Pressure Mattress 8"
Power Wheelchair Model C MOB1094
Dual Thermometer
Therapy Bar
Hand Exercise Eggs
Shoulder Pulley
Hand Contracture Orthosis Kit
Shoulder Pulley With Fabric Hook
Finger Ladder
Shoulder Pulley With Ergonomic Grip
Stretch Strap
Calf Stretcher
Mobilization Belt
Hand Exercise Balls
Hand Extension Exercisers
Wrist Sleeves
Push-Button Safety Lancets 30G
Push-Button Safety Lancets 28G
EMS TENS Unit RHB2026
Gel Mattress Overlay
Foot Bar
Elevating Leg Rest
Air Frame Wheelchair MOB1062
Portable Oxygen Concentrator Juniper Pro Sieve Bed
Juniper Pro 6 Setting Portable Oxygen Concentrator LVA3111
Portable Oxygen Concentrator Juniper Pro Filler Kit (int. and ext.)
Portable Oxygen Concentrator Juniper Pro DC Charger
Portable Oxygen Concentrator Juniper Pro AC Power Cord
Portable Oxygen Concentrator Juniper Pro AC Adapter
Portable Oxygen Concentrator Juniper Pro Carry Bag
Juniper 5 Setting Portable Oxygen Concentrator LVA3161
Portable Oxygen Concentrator Juniper Pro External Battery Charger
Portable Oxygen Concentrator Juniper Pro Battery
Transparent Film Dressing
Medical Paper Tape
Wound Closure Kit (Sterile)
Kinesiology Tape
Pre-Wrap Tape
Surgical Tape
Standard Blood Pressure Monitor DMD1087
Bariatric Wheelchair MOB1141
Heavy Duty Wheelchair MOB1078
Heavy Duty Wheelchair MOB1150
Island Dressing
Hydrocolloid Roll
Hydrocolloid Bordered Dressing (Sterile)
Hands Free Breast Pump (Model S21)
Patient Lift U Sling
Sock and Shoe Assist
Stand Assist Seat
Stand Assist Handle
Transfer Disc
Tubular Slide Sheet
Leg Lift Assist
Angled Stocking Donnor
Car Assist Strap
Leg Lifter
Bed Step Assist
Lift Sling with Opening
Suction Grab Bar
Step Stool with Handrail
Transfer Belt
Transport Stand Assist
Chair Transfer Sling
Transfer Sling
Portable Stand Assist
Multi Purpose Leg Lifter
Wooden Transfer Board
Patient Lift Sling
Multi Grip Leg Lifter
Floor To Ceiling Grab Bar
Transfer Belt with Handles Plastic Buckle
Easy Clean Transfer Belt
Transfer Belt Metal Buckle
Patient Lift Toilet Sling
Thigh Lifter
Car Assist Handle
Stand Assist Transfer Disc
Spill Proof Scoop Bowl
Transfer Blanket
Step Stool
Transfer Belt Plastic Buckle
Bed Ladder
Air Frame Aluminum Power Wheelchair MOB1107
639 LSO Pro
464 TLSO Pro
456 TLSO Pro
Back Brace
3 in 1 Step Down LSO
626 LSO Pro
637 LSO Pro
637 LSO Essential
627 LSO Essential
627 LSO Pro
Cross Support Back Brace
627 LSO Ultra
Hernia Belt
639 LSO Ultra
625 Back Brace
631 LSO Pro
637 LSO Ultra
621 SI Belt
631 LSO Essential
Industrial Bace Brace
626 LSO Ultra
631 LSO Ultra
Posture Corrector
626 LSO Essential
SI Belt
Long Handled Toe Washer Kit
Scoliosis Brace
Urinary Drainage Bags (Leg)
Urinary Drainage Bags (Bedside)
Blood Pressure Monitor DMD1068
Pulse Oximeter Compatible with Smart Devices DMD1046
8 Mode TENS Unit RHB1006
760 ROM Elbow Brace
The Bolt Shoulder Stabilizer
Stabilizing Elbow Brace
Shoulder Brace Cross Support
Humeral Fracture Splint (Upper)
Humeral Fracture Splint (Lower)
Hand and Wrist Immobilizer
ROM Elbow Brace
Post Op Shoe Round Toe
Shoe Lift Balancer
Envelop - 3/4 Length
Plantar Plus - Full Length Insoles
Gel Heel Cups
Plantar Series - 3/4 Length Insoles
Envelop - Full Length Gel
Post Op Shoe
Loop Toe Spacers (8 Pack)
Plantar Series - Full Length Insoles
Envelop Full Length
Bluetooth Pulse Oximeter
Electric Wheelchair Model V MOB1054
Wireless Tens Unit
RHB1006 Muscle Massager TENS Unit 8 mode
Catheter Bag Holder
Catheter Leg Bag Straps
Catheter Leg Bag Holder Sleeves
Air Frame Power Wheelchair - Magnesium Collection MOB1125
Offset Cane Soft Grip
Carbon Fiber Standing Cane
Offset Cane
Aluminum Bariatric Cane
LED Folding Cane
Offset Bariatric Cane
Folding Offset Cane
Stand Assist Cane
Stair Assist Cane
Carbon Fiber Cane
Walking Cane with Seat
Folding Cane
Quad Cane
Carbon Fiber Quad Cane
Folding Offset Swivel Cane
Cane with Seat
Full Chair Incontinence Pads
Disposable Underpads
Chair Incontinence Pads
Cast Tape
Silicone Scar Tape
King Neptune Mobility Scooter MOB1128
TeleRPM BPM
TeleRPM Blood Pressure Monitor Replacement Cuff XL
TeleRPM Blood Pressure Monitor Replacement Cuff Large
Patella Strap
Knee Immobilizer
Offloader Elite
OA CoreWrap
Hinged Knee Wrap
Stabilizing Knee Sleeve
ITB Brace
ACL Knee Brace
SAFS
397 Suspension Sleeve
Groin Support
Groin Brace
Sciatica Calf Brace
Offloader Elite Wrap
Single Panel Knee Immobilizer
Tri Panel Knee Immobilizer
Knee Brace
ROM Knee Brace
OA Knee Brace
Calf Brace
Hinged Knee Brace
CoreTrack Patellar Stabilizer
ROM Hinged Knee Brace
Elbow Brace
Offloader Knee Wrap
Dual Patella Strap
Heavy Duty Hinged Knee Brace
ROM Knee Brace Elite
Universal Knee Brace
Tennis Elbow Strap
Knee Support
Compression Bicep Strap
Thigh Brace
Shin Wrap
Dual Offloader
Easy Clean Wheelchair Armrest
Wheelchair Gel Set Cushion
Oxygen Cylinder Shoulder Bag
Wheelchair Seatbelt
Air Seat Cushion
Solid Seat Insert Foldable
Full Wheelchair Cushion
Foldable Wheelchair Cushion
Lateral Wheelchair Armrest
Wheelchair Backrest Cushion
Wheelchair Bag
Wheelchair Harness (Waist and Pelvic)
Torso Support Wheelchair Harness
Wheelchair Footrest Extender
Wheelchair Armrests
Memory Foam Wheelchair Cushion
Rollator Seat Bag
Wheelchair Cushion
Under Seat Wheelchair Harness
Walker Basket
Power Wheelchair Seat Cover and Cushion
Rollator Bag
Waist and Pelvic Wheelchair Harness
Rollator Travel Bag
Wheelchair Tray
Ergonomic Rollator Bag
Oxygen Tank Holder Dual
Mobility Scooter Seat Bag
Mesh Wheelchair Bag
Sheepskin Wheelchair Seat and Backrest Pads
Walker Bag
Oxygen Cylinder Bag
Oxygen Tank Holder
Mobility Side Bag
Easy Clean Wheelchair Cushion
Air Frame Rollator Carry Bag
Body Fat Scale Compatible with Smart Devices
Digital Tens Unit
Lightweight Arm Cast Cover
Lightweight Leg Cast Cover
Leg Cast Cover
Waterproof Arm Cast Cover
Arm Cast Cover
Arm Cast Cover Protection Tall
Arm Cast Cover Protection Short
960 Advanced Arm Sling
670 Arm Sling
670 Advanced Arm Sling
670 Universal Arm Sling
916 Wrist Brace
BPM DMD1038
Transport Wheelchair
Core Transport Wheelchair
Air Frame Wheelchair
Core Shower Commode Transport Wheelchair
Lightweight Transport Wheelchair
Drain Sponge
Gauze Rolls
Gauze Pads
Neptune Mobility Scooter MOB1126
Wrist Brace
Mobility Scooter (King Neptune)
DMD1017 Stethoscope
RHB2026 EMS Tens Unit
Vertical Rocker Knife
Nosey Dysphagia Cup
Plate Guard
One Pull Can Opener
Stainless Steel Weighted Utensil Set
Spill Proof Drinking Cup
Spill Proof Scoop Plate
Waterproof Shower Protector Patch
Super Absorbant Wound Dressing
Calcium Alginate Dressing
Gelling Fiber Wound Dressing
Lidocaine Patches 4%
Non Adherent Pads
Hydrocolloid Bordered Dressing
Compressor Nebulizer Kit, Disposable
Aerosol Mask for Nebulizer
Compressor Nebulizer Air Filter
Compressor Nebuliser Kit, Reusable
Compressor Nebulizer
Silver Alginate Dressing
Pediatric Compressor Nebulizer
Electric Patient Lift with Sling
Electric Patient Lift
Hemostatic Gauze
60 Mode TENS and EMS Unit
50 Mode TENS and EMS RHB3004
Blood Pressure Monitor DMD1064
Bariatric Wheelchair MOB1102
Active Wheelchair MOB1101
Reclining Wheelchair With Headrest MOB1103
Core Wheelchair MOB1100
Benchmark Wheelchair MOB1143
Bed Pan
Maternity Belt
Umbilical Hernia Belt
Inguinal Hernia Belt
Instant Ice Packs
Lidocaine Patch
Heel Wedge Post Op Shoe
Offloading Post Op Shoe
Closed Toe Post Op Shoe
Hard Night Splint
Soft Night Splint
4 Wheel Air Frame Walker with Bag
Twin Trays Rollator
Core Upright Walker
Rollator, Wheelchair, Walker
Core Rollator
4 Wheel Air Frame Walker
Walker Wheels
Bariatric Carbon Fiber Rollator
Core Walker
Everglide Rollator
Tri-Rollator
Sunstride Rollator Walker
Carbon Fiber Rollator
Tri-Rollator with Seat
Lightweight Aluminum Walker
Upright Walker
Knee Walker
Bariatric Rollator
Walker Forearm Platform
Compact Air Frame Walker with Non Slip Tips
Core All Terrain Knee Walker
Hemi Walker
Wheelchair Rollator
Lightweight Rollator
Core Carbon Fiber Rollator 2
Compact Air Frame Wlaker
Rollator With Cupholder Tray
SunStride Rollator All Terrain
Walker Wheels with Brakes
Core Knee Walker
Folding Walker
Upright Walker Series T
Core Rollator 8" Wheel
All Terrain Knee Walker
Lightweight Aluminum Walker with Wheels
Aluminum Lightweight Rollator
CarbonGlide Rollator
Sunstride Rollator
Core Carbon Fiber Rollator
Bariatric Walker with Wheels
Walker Wheels and Glides
CustomFit Rollator
Stand Assist Walker
Nitrile Exam Gloves
Bariatric Wheelchair
Abdominal Binder 2 Panel
Compression Wrap System Lower Leg
Breast Pump Dual
Breast Pump Single
Reusable Incontinence Pad
Waterproof Non Slip Cover
Waterproof Mattress Protectors
Neck Support Brace
Cervical Pillow
172 Cervical Collar
174 Cervical Collar
Waterbase Pillow
CPAP Pillow
Cervical Collar - Neck Brace Thin 3''
180 Cervical Collar
Cervical Collar - Neck Brace Thin 4''
Cervical Collar
Hydraulic Patient Lift with Sling
Core Hydraulic Patient Lift
Hydraulic Patient Lift
Core Hydraulic Patient Lift with Sling
Wireless TENS and EMS Unit RHB3052
Abduction Sling Advanced
Shoulder Immobilizer
Universal Arm Sling
Mesh Arm Sling
Arm Sling
Abduction Sling
Xeroform Petrolatum Dressing
Fall Protection Helmet
Coccyx Cushion
Infrared Thermometer
Emesis Bags
Elastic Bandages
Elastic Tubular Bandage
Dr. Pat's Cold Compression Bandage
Multi Layer Compression Bandage System
Overbed Table
Sphygmomanometer
Alternating Seat Cushion
Skin Protectant Wipes
Unna Boot Bandage with Zinc Oxide and Calamine
DMD1046 Bluetooth Pulse Oximeter
Dementia Hand and Foot Restraints
Elderly Restraint Mittens
Vest Restraint
Elderly Bed Restraint
Ice Therapy Machine
Cold Therapy System
Digital Scale with Smart Phone Capability
Ostomy Bag 2 Piece
Ostomy Bag 1 Piece
Silver Antimicrobial Wound Gel
Walker Ski Glides Adjustable
Foam Knee Walker Pad with Comfort Gel
Tennis Ball Walker Glides
Fleece Crutch Pads With Hand Grips
Crutch Pads with Ergonomic Pouch
Sheepskin Walker Grips
Replacement Cane Tips
Fleece Crutch Pad Cushion
Shock Absorbing Cane Tip (2 Pack)
Velvet Crutch Pads with Hand Grips
Ice Cane Tip
Knee Walker Pad Foam and Gel
Crutch Pad Kit
Cane Pad Hand Grip Cover
Walker Grip Pads
Walker Ski Glides Adjustable With Covers
Fleece Crutch Pads
Standing Cane Tip
Upright Walker Forearm Pads
Quad Cane Replacement Tips
Crutch Pads
Sheepskin Knee Walker Pad
Foam Knee Walker Pad
Velvet Crutch Pads
Weight Scale
Hot and Cold Jaw Wrap
Hot and Cold Wrist Sleeve
Hot And Cold Bunion Ice Sleeves
Breast Ice Packs
Hot and Cold Therapy Gel Sleeve
Ice Eye Mask
Wheelchair Seat Cooling Pad
Shoulder Ice Wrap
Hot and Cold Shoulder Sleeve
LSO Ice Packs Coretech
Ice Bag
Leg Ice Pack
Calf Ice Pack
14x13" Ice Wrap
Back and Stomach Hot and Cold Pack
Neck Ice Pack Cryogrid
Hot and Cold Ankle Sleeve
Replacement Ice Packs For Compression Knee Ice Brace
Knee Ice Wrap Cryogrid
Ice Cup
Knee Hot And Cold Pack
Wrist Ice Wrap Cryogrid
Back and Stomach Ice Pack
Hot and Cold Eye Mask
Elbow Ice Wrap
Replacement Ice Gel Packs
Wrist Ice Pack
Shoulder Compression Ice Wrap
Back Ice Pack
Hip Ice Pack
Elbow Compression Ice Wrap
Shoulder Ice Pack
Hot and Cold Wrap
Ankle Ice Wrap
Elbow Ice Pack
Ice Pack
Calf Hot and Cold Pack
Hot and Cold Arch Wraps
Hot and Cold Ergonomic Wrap
Ice Wrap Replacement Packs
Back Compression Ice Wrap
Ice Pack 11x14"
LSO Ice Pack
Full Head Ice Wrap
Multi-Purpose Ice Wrap
Hot and Cold Foot Sleeve
Hot and Cold Finger Sleeves
Hot and Cold Wrist Wraps
Knee Compression Ice Wrap
Hot and Cold Multipurpose Wrap
Hot and Cold Back Gel Wrap
Neck Ice Pack
Wrist Ice Wrap
Ice Pack - 11" x 24"
Replacement Ice Packs For Ankle Compression Ice Wrap
Breast Ice Pack
Wrist Compression Ice Wrap
Hot And Cold Neck Sleeve
Knee Hot and Cold Pack
Knee Ice Wrap
Back Ice Wrap
Wheelchair Backrest Cooling Pad
Ice Therapy Gloves
Hot and Cold Multi-Purpose Wrap
Ankle Compression Ice Wrap
Collagen Wound Dressing
Portable Sequential Compression System
Wrist BPM
IV Pole
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198