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Wheelchair seat cushion
EUDAMEDFDA UDIClass I (EU MDR)
Ref PXSP1514BLKModel Seating
Identity
- Trade Name
- Wheelchair seat cushion EUDAMEDAxiom FDA UDI
- Generic Name
- Wheelchair seat cushion FDA UDI
- Device Name
- Pediatric Axiom Skin Protection And Positioning Cushion 15 X 14, Black FDA UDI
- Model / Reference
- Seating EUDAMEDPXSP1514BLK EUDAMEDPXSP FDA UDI
- Description
- Pediatric Axiom Skin Protection And Positioning Cushion 15 X 14, Black FDA UDI
Identifiers
- Catalog Number
- PXSP1514BLK FDA UDI
- Primary DI / UDI-DI
- 00840363365091 EUDAMEDFDA UDI
- Basic UDI-DI
- 08403633SEATINGK7 EUDAMED
- FDA Product Code
- IMP FDA UDI
- EMDN Code
- V080399 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
- 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 seat cushion 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 | 08403633SEATINGK7 | 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 b3c10a32-ba7c-401a-9fd2-5d9f830c28f7 61 fields · synced Jun 17, 2026
- FDA UDI a913a7d3-fd1a-460e-a90a-f69f8e50f25c 36 fields · synced May 30, 2026