FDA Registration
Active
🇺🇸 United States
CORE PRODUCTS INTL., INC.
Reg #: 2183988
·
FEI: 1000115743
·
Expires 2026
Products
13
Proprietary Names
219
Establishment Types
3
Classifications
13
Registration Details
- Registration Name
- CORE PRODUCTS INTL., INC.
- Registration Number
- 2183988
- FEI Number
- 1000115743
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 808 PROSPECT AVE.
- City
- OSCEOLA
- State
- WI
- ZIP
- 54020
- Country
- US
Owner / Operator
- Firm Name
- Core Products International, Inc.
- Operator Number
- 9002815
- Address
- 808 Prospect Avenue, --
- City
- Osceola
- State
- WI
- Postal Code
- 54020
- Country
- US
- Correspondent
- Paul R Norstrem
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2017-05-24 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2017-05-23 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2006-10-18 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2017-05-23 |
| Head Halter, Traction | IRS | Class 1 | Physical Medicine | No | 1992-07-22 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2010-12-15 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 2016-07-25 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2006-09-21 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2017-05-23 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 1992-07-22 |
| Components, Exercise | IOD | Class 1 | Physical Medicine | No | 2011-12-07 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2016-05-16 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2010-12-15 |
Proprietary Names
Swede-O Elastic Performance Sock, pair
Swede-O Thermal Vent CT Immobilizer
Swede-O Thermal Vent Wrist Forearm Splint
Swede-O Thermal Vent CT Brace w/Thumb Spica
Swede-O Thermal Vent Universal Thumb Spica
Swede-O Thermal Vent Universal Wrist Wrap
Swede-O Carpel Tunnel Glove
Swede-O Thermal Vent Wrist Hand CT Brace
Swede-O Dorsal Night Splint
Swede-O Pediatric Walking Boot
Swede-O Deluxe Night Splint
Swede-O Adjustable Night Splint
Swede-O Step Smart
Swede-O Walking Boot, Tall
Swede-O Walking Boot, Short
CAST
SHOE
Swede-O Oped X8 Ankle Brace
Swede-O Thermal Vent Ankle Foot Stabilizer
Swede-O Thermal Vent Ankle Wrap
Swede-O Trim Lok Ankle Brace
Swede-O Thermal Vent Ankle Sleeve
Swede-O Versi-Splint
Swede-O Thermal Vent Therapeutic Foot Relief
Swede-O Inner Lok 8 Ankle Brace
Swede-O Thermal Vent Heel Rite
Swede-O Elastic Ankle
Swede-O Thermal Vent Plantar DR
Swede-O Arch Lok Ankle
Swede-O Strap Lok Ankle Brace
Swede-O Ankle Lok Brace
Swede-O Easy Lok Ankle Brace
Swede-O Tarsal Lok Ankle Brace
TRACTION UNIT
Swede-O Thermal Vent Knee Patella Tracker
Swede-O Thermal Vent Knee Sleeve
Swede-O Thermal Vent Adjustable Knee Stabilizer
Swede-O Thermal Vent Knee Stabilizer
Swede-O Elastic Knee Support
Swede-O Thermal Vent Knee Wrap
Swede-O Thermal Vent Knee Patella
Swede-O Elastic Knee Stabilizer
Swede-O Elastic Knee Tetra-Stretch
Swede-O Thermal Vent Open Wrap Hinged Knee
Swede-O Thermal Vent Open Knee Wrap Stabilizer
Swede-O Thermal Vent Open Wrap ROM Hinged Knee
Breathable Body Shield
Breathable Trochanter
Foam Collars with vinyl straps
Foam Collars
Posture Corrector
Rib Belts
Chest Cushion
Peak Bolster
Knee Elevator
Dutchman Roll
Deluxe Chest Cushion
Half Round Bolster
Fluffy Bolster
60" Body Pillow
60" Body Pillow Staphcheck
Knee Bolster
The M.A.T.
Deluxe Knee Wedge
LIMB
TRUNCAL-ORTHOSIS
Swede-O Thermal Vent Hinged Elbow
Swede-O Elastic Elbow Support
Swede-O Thermal Vent Universal Shoulder Wrap
Swede-O Thermal Vent Hinged ROM Elbow
Swede-O Thermal Vent Tennis Elbow Strap w/Pad
Swede-O Thermal Vent Elbow Sleeve
Swede-O Thermal Vent Elbow Wrap
Perfect Posture Corrector
Spinal Relief Pillow
Body Shield Ab Binder-9"
Molded Lumbar Bucketseat Cushion
Basic Cervical Firm
Bucket Sitback Rest Standard
D-Core
Body Shield Ab Binder-12"
Lobak Rest
AB Contour Satin
Ladies Comfort Cushion
Dual Pull Crisscross
Petite Core Printed
Adult Pelvic Blocks
Petite Core White
Air-Core Adjustable
Double Core Firm/X-Firm
Cervitrac Gentle
Sooth-A-Ciser Cotton/Poly Cover
Slimrest Standard Firm
Baby Hugger Single w/Extra underpant
Elastic Industrial Belt
Ladies Comfort Cushion Deluxe
Printed Sitback Rest
Bed Wedge 10"
Sitback Rest Deluxe
Tri-Core Standard
Multi Brace 627
CorFit Advantage
Maternity Support
Luniform Half Roll
Sitback Rest w/ hot & cold pack
Semi-Universal Trochanter
Jackson Roll
CorFit Industrial Belt
Bucket Sitback Rest Deluxe
Body Control Ab Binder-12"
Sitback Mesh Backrest
Core Memory Full-Size
Leg Spacer Petite
Baby Hugger Extra Underpant only
Tri-Core Excel Standard
Body Control Ab Binder-9"
CervAlign 5"
Leg Spacer Standard
CorFit Belt
Slimrest Deluxe Firm
Econo Leg Spacer w/cover-Std.
Tri-Core Comfort Zone-Std.
CorFit Trochanter
Hiback Rest, Large
Cervical Roll, Soft
Contoured CorBack w/Vinyl Pulls
Multi Brace 637
Molded Lumbar Cushion
Dutchman Roll Bolster 8 x 18
Canvasback
Cervitrac Standard
Sitback Plus
Body Shield Trochanter Belt
Foam Half Roll 12 x 2 1/2
Baby Hugger Single
Sooth-A-Ciser Vinyl Cover
Corebak Support
Tri-Core Excel GentleStandard
Stress Wedge
Super Lift
Adjustable Travel Roll
Leg Spacer Econo Standard
Core CPap Pillow-3"
Mini Core Cpap Pillow-3.5" H
Memory Face Cradle (Vinyl)
Dutchman Roll Bolster 6 x 18
Half Round 3 x 6 x 24
Elastic Trochanter
Mid-Core Comfort Zone
Fusion
Comfort Core w/ Adj. Backrest
Sooth-A-Ciser with Hot and Cold Pack
Bed Wedge
Tri-Core Gentle
Travel Core
Foam Roll 12 x 5
Mesh D-Roll Black
Triple Pull Elastic Belt
Sitback Rest Standard
Ventilated Elastic Support Belt
Sherpa Memory Face Cradle
WondaWedge
Triple Pull Elastic Belt w/pad
Mid-Core Gentle
Wraptor
Body Shield Rib Belt
Cervical Roll, Firm
Bed Wedge 12"
Inflatable Backrest
Core Memory Mid-Size
Sitback Plus II
Snuggle Foam Cervical Pillow
Apex Cervical Adjustable Orthosis
Snuggle Memory Foam Body Pillow
Snuggle Foam Travel Pillow
Swede-O Elastic Back Stabilizer
Swede-O Thermal Vent Lumbar Support
Therapeutica Bucket seat Lumbar Support Cushion
Swede-O Thermal Vent LSO
Rib Belt
Therapeutica Lumbar Support Cushion
THERAPEUTICA CERVICAL SLEEPING PILLOW LITE
Apex Cervical Orthosis Premium
Apex Cervical Orthosis Premium with Heat
Teardrop Pillow
Memory Air-Core
Memory Plus
Perfect Rest
Therapeutica Orthopedic Sleeping Pillow
Spine Saver Wedge
Luniform
Bowtie Pillow
Symphy Support
Hibak Rest
Double Core Select
Lil' Lift
Better Binder
Econo-Wave
Headache Ice Pillow
Comfort Core Backrest
Max-Relax Face Cushion
PowerWrap Corfit Belt
CerviLoft Adjustable Cervical Comfort Pillow
Tri-Core Natural Cervical Pillow Gentle Support
Adjusta-Loft Fiber Comfort Pillow
Tri-Core Natural Cervical Pillow Standard Support
The Original Wonder Disc
Sleep Log Pillow
Exercise and Therapy Rollers
Therapeutica Spinal Back Support
Therapeutica Travel Sleeping Pillow
Therapeutica Cervical Sleeping Pillow Lite
Therapeutica Molded Lumbar Support
Therapeutica Spinal Support Plus
Therapeutica Cervical Sleeping Pillow
Tri-Core Ultimate Cervical Support Pillow
Therapist Thumb
Swede-O Plantar F3 Foot Roller
Omni
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)