Identity
- Trade Name
- Axiom P EUDAMEDFDA UDI
- Generic Name
- Wheelchair seat cushion FDA UDI
- Device Name
- AXIOM CUSHION P FDA UDI
- Model / Reference
- Seating EUDAMEDAxiom P EUDAMEDXP1622C2 EUDAMEDP FDA UDI
- Description
- AXIOM CUSHION P FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850013379194 EUDAMEDFDA UDI00840363376967 EUDAMED
- Basic UDI-DI
- 0850013379SEATINGAG EUDAMED08403633SEATINGK7 EUDAMED
- FDA Product Code
- IMP FDA UDI
- EMDN Code
- V080302 PATIENT POSITIONING MEDICAL CUSHIONS EUDAMEDV080399 MEDICAL CUSHIONS - OTHER 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 EUDAMEDSweden 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 P 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 (3)
- EUDAMED 7a18007b-3b60-437c-bb27-0393dd8ee917 61 fields · synced Aug 1, 2026
- FDA UDI 3edee9b7-e6a7-4a3a-9206-0c8fde6e6c40 34 fields · synced May 30, 2026
- EUDAMED 88970904-f33e-40c3-9bf7-a517016226ac 61 fields · synced Aug 1, 2026