Identity
- Trade Name
- JAY XTREME ACTIVE EUDAMEDJay FDA UDI
- Generic Name
- Gel-filled chair cushion FDA UDI
- Device Name
- Jay Cushion EUDAMEDThe JAY Xtreme Active is a lightweight and low profile wheelchair cushion for active performance and easy transfers. Designed to provide both pressure relief and stability to active users, the JAY fluid pad insert maximises skin protection and reduces shear on the active user. The dual cover system promotes air flow and dissipates heat and moisture effectively. Thigh positioning can be achieved through retrofittable leg support components. FDA UDI
- Model / Reference
- Xtreme Active Cushion EUDAMEDFDA UDI
- Description
- The JAY Xtreme Active is a lightweight and low profile wheelchair cushion for active performance and easy transfers. Designed to provide both pressure relief and stability to active users, the JAY fluid pad insert maximises skin protection and reduces shear on the active user. The dual cover system promotes air flow and dissipates heat and moisture effectively. Thigh positioning can be achieved through retrofittable leg support components. FDA UDI
Identifiers
- Catalog Number
- Jay FDA UDI
- Primary DI / UDI-DI
- 00016958056778 EUDAMEDFDA UDI
- Basic UDI-DI
- 0016958jaycushions23 EUDAMED
- Direct Marketing DI
- 00016958056778 EUDAMED
- FDA Product Code
- IMP FDA UDI
- EMDN Code
- Y180980 SEATING SYSTEMS / POSTURE SYSTEMS / SEATING AIDS - ACCESSORIES EUDAMED
- GMDN Term
- Gel-filled chair cushion FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3920 FDA UDI
- Market of Registration
- Germany 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
Jay Xtreme Active by Sunrise Medical (US) 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 | 0016958jaycushions23 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sunrise Medical (US) LLC
- EUDAMED SRN
- US-MF-000007254
- Authorised Representative
- Sunrise Medical GmbH DE-AR-000006321
Sources (2)
- EUDAMED 1eb94cee-4725-4428-ae9b-1a19166995d3 61 fields · synced Jul 10, 2026
- FDA UDI b4a2bae7-0137-4fe8-b406-126f11142f0a 34 fields · synced May 30, 2026