Identity
- Trade Name
- Wheelchair bracket EUDAMEDAxiom FDA UDI
- Generic Name
- Wheelchair bracket/mount FDA UDI
- Device Name
- 3 x 4 Lateral Pads with Swing Away Mounting Hardware - Pair FDA UDI
- Model / Reference
- Backs EUDAMEDPBLS3X4PP EUDAMEDPB FDA UDI
- Description
- 3 x 4 Lateral Pads with Swing Away Mounting Hardware - Pair FDA UDI
Identifiers
- Catalog Number
- PBLS3X4PP FDA UDI
- Primary DI / UDI-DI
- 00840363306063 EUDAMEDFDA UDI
- Basic UDI-DI
- 08403633AXIOMHARDSOFTRC EUDAMED
- FDA Product Code
- KNO FDA UDI
- EMDN Code
- Y122499 WHEELCHAIRS ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Wheelchair bracket/mount FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3910 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Wheelchair bracket 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 | 08403633AXIOMHARDSOFTRC | 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 f9c7fb6f-1e42-47dc-b041-fa0d33ef4e2b 61 fields · synced Jul 15, 2026
- FDA UDI a8f2eaaf-5877-4cf3-a962-da4995c122e5 36 fields · synced May 30, 2026