Identity
- Trade Name
- Comfort Soft Headrest EUDAMEDAxiom FDA UDI
- Generic Name
- Wheelchair bracket/mount FDA UDI
- Device Name
- Comfort Soft Headrest, 14" with Multi-Axis Removable Adjustable Hardware FDA UDI
- Model / Reference
- Backs EUDAMEDCS14MA EUDAMEDHead Support FDA UDI
- Description
- Comfort Soft Headrest, 14" with Multi-Axis Removable Adjustable Hardware FDA UDI
Identifiers
- Catalog Number
- CS14MA FDA UDI
- Primary DI / UDI-DI
- 00840363305851 EUDAMEDFDA UDI
- Basic UDI-DI
- 08403633AXIOMHARDSOFTRC EUDAMED
- FDA Product Code
- KNO FDA UDI
- EMDN Code
- Y122499 WHEELCHAIRS ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Wheelchair bracket/mount FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3910 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
Comfort Soft Headrest 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 | 08403633AXIOMHARDSOFTRC | 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 00d7a031-fedd-461b-bab3-9ad543bcf497 61 fields · synced Jun 17, 2026
- FDA UDI df3f5387-df22-47dd-aa39-cbf2ab6722b0 36 fields · synced May 30, 2026