Identity
- Trade Name
- J2 Plus EUDAMEDJay FDA UDI
- Generic Name
- Gel-filled chair cushion FDA UDI
- Device Name
- Jay Cushion EUDAMEDThe JAY J2 Plus is a pre-contoured foam bariatric wheelchair cushion that offers a weight capacity of 650 pounds. FDA UDI
- Model / Reference
- J2 Plus Cushion EUDAMEDJ2 Plus FDA UDI
- Description
- The JAY J2 Plus is a pre-contoured foam bariatric wheelchair cushion that offers a weight capacity of 650 pounds. FDA UDI
Identifiers
- Catalog Number
- K0669 FDA UDI
- Primary DI / UDI-DI
- 00016958046212 EUDAMEDFDA UDI
- Basic UDI-DI
- 0016958jaycushions23 EUDAMED
- Direct Marketing DI
- 00016958046212 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
J2 Plus 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 3df449cf-1fe3-4d5e-8fbe-b1d2e24202f6 61 fields · synced Oct 6, 2026
- FDA UDI b6480c5b-1563-4632-80ac-c6289033d594 34 fields · synced May 30, 2026