FDA UDI
In Commercial Distribution
🇺🇸 United States
Recline Body-Fit System, Seat Frame Assy
DI: 07540147001803
·
Model: D-0104-BFS
·
Motion Concepts Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Recline Body-Fit System, Seat Frame Assy
- Primary DI
- 07540147001803
- Version / Model
- D-0104-BFS
- Catalog Number
- BFS2; BFS4
- 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
- 2025-03-18
- Public Version Status
- Update
- Public Device Record Key
- 23b795f1-4948-45cc-8dfc-490d9ff30d60
Device Description
Seat Frame Assembly for the Recline Body-Fit System. The Recline Body-Fit System is designed to allow for installation of narrower (offset) back canes (optional 2" or 4" cane offset available). (A minimum 16H back height required). These wheelchair components are designed for use with Motion Concepts Power Positioning Systems with Recline.
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 |
|---|---|---|---|---|
| 37744 | Wheelchair bracket/mount | A device designed to be attached to a wheelchair to mount a portable accessory (e.g., holder, bag) [not included], as part of wheelchair adaption/customization. It may be in the form of e.g., a rack, adaptor, or clamp. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540147001803 | GS1 |
Customer Contacts
- Phone
- 1-888-433-6818
- [email protected]