Identity
- Trade Name
- Axiom SPV EUDAMEDFDA UDI
- Generic Name
- Wheelchair seat cushion FDA UDI
- Device Name
- AXIOM CUSHION SP VISCO FDA UDI
- Model / Reference
- Seating EUDAMEDAxiom SPV EUDAMEDSPV FDA UDI
- Description
- AXIOM CUSHION SP VISCO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850013379156 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850013379SEATINGAG EUDAMED
- FDA Product Code
- IMP FDA UDI
- EMDN Code
- V080302 PATIENT POSITIONING MEDICAL CUSHIONS EUDAMED
- GMDN Term
- Wheelchair seat cushion 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 SPV 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ki Mobility LLC
- EUDAMED SRN
- US-MF-000012633
- Authorised Representative
- Ki Mobility Portugal, Unipessoal Lda PT-AR-000012557
Sources (2)
- EUDAMED d5b8e155-73be-4c6a-a6ba-dd7217f9cc8e 61 fields · synced Jun 18, 2026
- FDA UDI 15e6dd9f-2276-42da-939c-33d91d806add 34 fields · synced May 30, 2026