FDA UDI
In Commercial Distribution
🇺🇸 United States
WHEELCHAIR HANDRIM
DI: 00606509900218
·
Model: WHEELCHAIR HANDRIM
·
Pride Mobility Products Corp
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WHEELCHAIR HANDRIM
- Primary DI
- 00606509900218
- Version / Model
- WHEELCHAIR HANDRIM
- Catalog Number
- N/A
- Company Name
- Pride Mobility Products Corp
- Labeler DUNS
- 041477449
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-26
- Public Version
- 2
- Public Version Date
- 2023-03-03
- Public Version Status
- Update
- Public Device Record Key
- f076a685-db12-44bd-878a-3678e4282485
Device Description
A device typically made of metal, wood, and synthetic materials that is attached to the large wheels of a wheelchair to enhance the wheelchair occupant's ability/efficiency to self propel the wheelchair using at hand and arm power. It provides ergonomic surfaces for the thumb and the palm of the hand, eases stress on the shoulder and wrist, prevents fingers and thumb from getting caught by any part of the wheel, and improves gripping contact area.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IMO | Handrim, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32984 | Wheelchair handrim | A device typically made of metal, wood, and synthetic materials that is attached to the large wheels of a wheelchair to enhance the wheelchair occupant's ability/efficiency to self propel the wheelchair using at hand and arm power. It provides ergonomic surfaces for the thumb and the palm of the hand, eases stress on the shoulder and wrist, prevents fingers and thumb from getting caught by any part of the wheel, and improves gripping contact area. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00606509900218 | GS1 |