Identity
- Trade Name
- Axiom LB EUDAMEDAxiom Back FDA UDI
- Generic Name
- Wheelchair back rest FDA UDI
- Device Name
- AXIOM LATERAL BACKREST FDA UDI
- Model / Reference
- Seating EUDAMEDAxiom LB EUDAMEDAXLB FDA UDI
- Description
- AXIOM LATERAL BACKREST FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850013379163 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850013379SEATINGAG EUDAMED
- FDA Product Code
- KNN FDA UDI
- EMDN Code
- Y121821 RETRACTORS, BACKRESTS, BRACKETS AND SUPPORTS EUDAMED
- GMDN Term
- Wheelchair back rest FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3920 FDA UDI
- Market of Registration
- Portugal 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
Axiom LB 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 | 0850013379SEATINGAG | 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
- Ki Mobility Portugal, Unipessoal Lda PT-AR-000012557
Sources (2)
- EUDAMED 19454b91-34ec-439b-b165-5499060291a7 61 fields · synced Jul 14, 2026
- FDA UDI cf656dea-ee95-4712-8ff8-620a7d998881 34 fields · synced May 30, 2026