FDA Registration
Active
🇺🇸 United States
DMS HOLDINGS, INC.,
Reg #: 1422443
·
FEI: 1000143485
·
Expires 2026
Products
61
Proprietary Names
17
Establishment Types
1
Classifications
61
Registration Details
- Registration Name
- DMS HOLDINGS, INC.,
- Registration Number
- 1422443
- FEI Number
- 1000143485
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- Dba/Healthsmart International, 1931 Norman Dr
- City
- Waukegan
- State
- IL
- ZIP
- 60085
- Country
- US
Regulatory Submissions
- 510(k) Number
- K962778
Owner / Operator
- Firm Name
- DMS HOLDINGS DBA HealthSmart International
- Operator Number
- 9005245
- Address
- 1931 NORMAN DR., --
- City
- Waukegan
- State
- IL
- Postal Code
- 60085
- Country
- US
- Correspondent
- Jerry Esses
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cane | IPS | Class 1 | Physical Medicine | No | 2006-02-16 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2007-08-14 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | No | 2023-08-31 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2023-09-01 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2006-02-16 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 2023-09-01 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2007-08-14 |
| Restraint, Protective | FMQ | Class 1 | General Hospital | No | 2008-02-28 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2007-08-14 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2024-01-09 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 1994-04-01 |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | Class 2 | General Hospital | No | 2021-05-27 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 1994-05-05 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2023-09-06 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2020-06-29 |
| Pill Crusher/Cutter | OHY | Class 1 | General Hospital | No | 2023-08-31 |
| Chair And Table, Medical | KMN | Class 1 | General Hospital | No | 2023-09-06 |
| Device, Incontinence, Urosheath Type, Non-Sterile | NNX | Class 1 | Gastroenterology, Urology | No | 2023-09-01 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2014-05-22 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2023-09-01 |
| Tips And Pads, Cane, Crutch And Walker | INP | Class 1 | Physical Medicine | No | 2007-08-14 |
| Board, Bed | FPS | Class 1 | General Hospital | No | 2007-08-14 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2023-09-01 |
| Attachment, Commode, Wheelchair | INB | Class 1 | Physical Medicine | No | 2006-02-16 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2011-05-13 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2007-08-14 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2023-08-31 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2021-05-27 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 1994-03-22 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2007-08-14 |
| Bottle, Hot/Cold Water | FPF | Class 1 | General Hospital | No | 2006-02-16 |
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2023-09-01 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2023-09-06 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2023-08-31 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2007-08-14 |
| Table, Mechanical | INW | Class 1 | Physical Medicine | No | 2023-09-01 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2007-08-14 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2025-06-27 |
| Scale, Platform, Wheelchair | INF | Class 1 | Physical Medicine | No | 2023-08-31 |
| Cover, Cast | KIA | Class 1 | General Hospital | No | 2023-09-01 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2023-08-31 |
| Belt, Wheelchair | IQB | Class 1 | Physical Medicine | No | 2023-09-01 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2023-08-31 |
| Utensil, Eating | ILC | Class 1 | Physical Medicine | No | 2023-09-01 |
| Bed, Manual | FNJ | Class 1 | General Hospital | No | 2023-08-31 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2023-08-31 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2007-08-14 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2023-08-31 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2026-04-17 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2023-09-06 |
| Components, Exercise | IOD | Class 1 | Physical Medicine | No | 2023-09-06 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2007-08-14 |
| Dispenser, Solid Medication | NXB | Class 1 | Physical Medicine | No | 2023-09-01 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2023-08-31 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2023-09-06 |
| Bedpan | FOB | Class 1 | General Hospital | No | 2007-08-14 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2023-08-31 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2006-02-16 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2025-06-27 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2023-09-01 |
| Restraint, Wheelchair, Non-Protective | KID | Class 1 | Physical Medicine | No | 2008-02-19 |
Proprietary Names
SwitchStick
DMI
Heelbo L-Bow Arm Restraint
Mabis
MABIS
HEALTHSMART
Heelbo
Heelbo Inch Limb Restraint
HealthSmart
Stein's
Mabis Steam Inhaler
SCOPE
CRYSTAL
CALIBER
SIGNATURE
LEGACY
Heelbo Chair Belt
Establishment Types
Complaint File Establishment per 21 CFR 820.198