Identity
- Trade Name
- Jay Syncra Back FDA UDI
- Generic Name
- Gel-filled chair cushion FDA UDI
- Device Name
- Syncra is a comprehensive seating system engineered so that the cushion and the back work in tandem to minimize movement and help avoid body displacement. The combination of the Syncra's scalloped back shell and the cushions' lowered pelvic wall and deeper femoral troughs assist in keeping the body in optimal position during the recline motion. FDA UDI
- Model / Reference
- Syncra Back FDA UDI
- Description
- Syncra is a comprehensive seating system engineered so that the cushion and the back work in tandem to minimize movement and help avoid body displacement. The combination of the Syncra's scalloped back shell and the cushions' lowered pelvic wall and deeper femoral troughs assist in keeping the body in optimal position during the recline motion. FDA UDI
Identifiers
- Catalog Number
- JAY FDA UDI
- Primary DI / UDI-DI
- 00016958059878 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Gel-filled chair cushion
Jay Syncra Back by Sunrise Medical (US) LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 2dc5d4cc-21d4-456d-bed5-f17ba61cc5ee 34 fields · synced Jun 9, 2026