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Axiom Posterior Back (PB)
EUDAMEDFDA UDIClass I (EU MDR)
Ref AXPB1408Model Backs
Identity
- Trade Name
- Axiom Posterior Back (PB) EUDAMEDAxiom FDA UDI
- Generic Name
- Wheelchair back rest FDA UDI
- Device Name
- Posterior Back 14W x 8H FDA UDI
- Model / Reference
- Backs EUDAMEDAXPB1408 EUDAMEDPB FDA UDI
- Description
- Posterior Back 14W x 8H FDA UDI
Identifiers
- Catalog Number
- AXPB1408 FDA UDI
- Primary DI / UDI-DI
- 00840363300030 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 — 8 Inch FDA UDI
Axiom Posterior Back (PB) 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 0abfe258-5c52-4f83-b487-83e0a136bb58 61 fields · synced Jul 10, 2026
- FDA UDI 5123c2f1-7bd8-4ee2-a8a8-073ea646fefa 36 fields · synced May 30, 2026