Identity
- Trade Name
- JAY Balance EUDAMEDJay FDA UDI
- Generic Name
- Gel-filled chair cushion FDA UDI
- Device Name
- Jay Cushion EUDAMEDCombining the high skin protection qualities of the JAY J2 wheelchair cushion with the stability and positioning capability of the J3, the JAY Balance wheelchair cushion adds exceptional comfort to ensure that there are no compromises. FDA UDI
- Model / Reference
- Balance Cushion EUDAMEDBalance FDA UDI
- Description
- Combining the high skin protection qualities of the JAY J2 wheelchair cushion with the stability and positioning capability of the J3, the JAY Balance wheelchair cushion adds exceptional comfort to ensure that there are no compromises. FDA UDI
Identifiers
- Catalog Number
- Jay FDA UDI
- Primary DI / UDI-DI
- 00016958056709 EUDAMEDFDA UDI
- Basic UDI-DI
- 0016958jaycushions23 EUDAMED
- Direct Marketing DI
- 00016958056709 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 Balance 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 8fdcae0e-cd5f-401e-8b96-3e0aa49ee48b 61 fields · synced Jul 9, 2026
- FDA UDI 0f779e83-51dd-499c-8b2b-ca09b38256e2 34 fields · synced May 30, 2026