Identity
- Trade Name
- Wheelchair back rest EUDAMEDAxiom FDA UDI
- Generic Name
- Wheelchair back rest FDA UDI
- Device Name
- Posterior Lateral Back 16W x 12H FDA UDI
- Model / Reference
- Backs EUDAMEDAXPL1612 EUDAMEDPL FDA UDI
- Description
- Posterior Lateral Back 16W x 12H FDA UDI
Identifiers
- Catalog Number
- AXPL1612 FDA UDI
- Primary DI / UDI-DI
- 00840363300443 EUDAMEDFDA UDI
- Basic UDI-DI
- 08403633BACKS9G EUDAMED
- FDA Product Code
- KNN FDA UDI
- EMDN Code
- Y122499 WHEELCHAIRS ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Wheelchair back rest FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3920 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 12 Inch FDA UDI
Wheelchair back rest by Ki Mobility, Llc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08403633BACKS9G | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ki Mobility LLC
- EUDAMED SRN
- US-MF-000012633
- Authorised Representative
- Etac Supply Center AB SE-AR-000001601
Sources (2)
- EUDAMED 91612a48-fde4-4ee6-a8f9-703ffd1d610c 61 fields · synced Jul 26, 2026
- FDA UDI 6b5c8297-0ebe-4fe0-a94a-845e3b0e7e89 36 fields · synced May 30, 2026