Identity
- Trade Name
- JAY LITE EUDAMEDJay Lite Cushion FDA UDI
- Generic Name
- Foam-filled chair cushion FDA UDI
- Device Name
- Jay Cushion EUDAMEDThe JAY Lite is an extremely lightweight foam wheelchair cushion that provides superior pressure distribution as well as heat and moisture dissipation. FDA UDI
- Model / Reference
- Lite Cushion EUDAMEDJay Lite Cushion FDA UDI
- Description
- The JAY Lite is an extremely lightweight foam wheelchair cushion that provides superior pressure distribution as well as heat and moisture dissipation. FDA UDI
Identifiers
- Catalog Number
- E2603, E2607 FDA UDI
- Primary DI / UDI-DI
- 00016958054002 EUDAMEDFDA UDI
- Basic UDI-DI
- 0016958jaycushions23 EUDAMED
- Direct Marketing DI
- 00016958054002 EUDAMED
- FDA Product Code
- IMP FDA UDI
- EMDN Code
- Y180980 SEATING SYSTEMS / POSTURE SYSTEMS / SEATING AIDS - ACCESSORIES EUDAMED
- GMDN Term
- Foam-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 Lite 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 bc62b9d1-33f5-485f-8d73-5577912d5cd4 61 fields · synced Jul 30, 2026
- FDA UDI f3264957-1158-4454-85d5-81c0e89e598b 34 fields · synced May 30, 2026