Wheelchair seat cushion
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Wheelchair seat cushion EUDAMEDAxiom FDA UDI
- Generic Name
- Wheelchair seat cushion FDA UDI
- Device Name
- Adjustable Skin Protection Cushion 15 x 15 FDA UDI
- Model / Reference
- Seating EUDAMEDXAS1515 EUDAMEDAS FDA UDI
- Description
- Adjustable Skin Protection Cushion 15 x 15 FDA UDI
Identifiers
- Catalog Number
- XAS1515 FDA UDI
- Primary DI / UDI-DI
- 00840363304281 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
A wheelchair seat cushion designed to provide comfort and support for individuals with mobility impairments. This device features a durable and adjustable design, allowing users to customize the position of the cushion to suit their individual needs. With its advanced materials and ergonomic construction, it is designed to reduce fatigue and discomfort during prolonged use.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 99f14e33-49e8-4e0c-8ee7-280756bc2fc6 61 fields · synced Jul 17, 2026
- FDA UDI 485c3a70-73d4-46d4-ade8-7eee45367e64 35 fields · synced May 29, 2026