FDA UDI
In Commercial Distribution
🇺🇸 United States
Flat Hand Pad
DI: 07540147002718
·
Model: D-0153-FHP
·
Motion Concepts Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Flat Hand Pad
- Primary DI
- 07540147002718
- Version / Model
- D-0153-FHP
- Catalog Number
- FHP
- Company Name
- Motion Concepts Inc
- Labeler DUNS
- 259777209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- 5d902b45-94c6-4e2d-a8a0-93f31635b075
Device Description
Flat Hand Pad. (Molded, skinned polyurethane hand pad designed for use in combination with the Ergonomic Arm Trough (sold separately)). The Flat Hand Pad is compatible with Left or Right Arm Troughs. Mounting hardware is included.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IML | Armrest, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32981 | Wheelchair armrest | A small platform, typically cushioned, mounted on the lateral ends of a wheelchair to provide the user with a support on which to place the arms. The position of the platform (e.g., height) may be adjustable to suit the comfort and utility of the user. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540147002718 | GS1 |
Customer Contacts
- Phone
- 1-888-433-6818
- [email protected]