Identity
- Trade Name
- Jay FDA UDI
- Generic Name
- Gel-filled chair cushion FDA UDI
- Device Name
- The JAY Duo wheelchair cushion features an integrated, contoured solid seat pan with a soft foam and fluid seat cushion. FDA UDI
- Model / Reference
- Duo FDA UDI
- Description
- The JAY Duo wheelchair cushion features an integrated, contoured solid seat pan with a soft foam and fluid seat cushion. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00016958041545 FDA UDI
- FDA Product Code
- IMP FDA UDI
- GMDN Term
- Gel-filled chair cushion FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3920 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Gel-filled chair cushion
Jay by Sunrise Medical (US) LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- DRIVE — Drive Devilbiss Healthcare · Class I
- Everest & Jennings — GF Health Products, Inc · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sunrise Medical (US) LLC
Sources (1)
- FDA UDI 49b9060b-0862-4ce2-9ca4-4ecd87fdb317 33 fields · synced Jun 9, 2026