FDA UDI
In Commercial Distribution
🇺🇸 United States
One-Piece Flat Calf Panel Pad
DI: 07540147002435
·
Model: D-0197-OPFCP
·
Motion Concepts Inc
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- One-Piece Flat Calf Panel Pad
- Primary DI
- 07540147002435
- Version / Model
- D-0197-OPFCP
- Catalog Number
- OSFCP
- 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
- 3
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 7c006c92-2fe2-4056-8076-a89e825beca8
Device Description
One-Piece Flat Calf Panel Pad use with Motion Concepts CM Legrests. (HR PU foam pad with black polyester fabric cover). Available in a variety of widths and heights to accommodate different user needs. Installs onto the corresponding sized One-Piece Calf Panel Assy.
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 |
|---|---|---|---|---|
| KNN | Components, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32982 | Wheelchair footrest/legrest | A platform (typically metal with or without a padded vinyl covering) usually mounted on a wheelchair in pairs, and upon which a wheelchair occupant may place the feet/legs for comfort, support, and/or to keep them off of the ground. It typically includes a mounting frame, footrest, and may include a mounted pad(s) to support the calves of the legs; it may be fixed or adjustable. | No | Active |
| 65005 | Wheelchair legrest pad | A contoured or padded device intended to be attached to wheelchair footrests so that it can provide a comfortable platform to support the calves of the legs (legrest). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540147002435 | GS1 |
Customer Contacts
- Phone
- 1-888-433-6818
- [email protected]