Identity
- Trade Name
- Jay Zip Cushion FDA UDI
- Generic Name
- Foam-filled chair cushion FDA UDI
- Device Name
- The JAY Zip is an anti-microbial, convenient, and comfortable skin protection and positioning wheelchair cushion designed specifically for kids! FDA UDI
- Model / Reference
- Jay Zip Cushion FDA UDI
- Description
- The JAY Zip is an anti-microbial, convenient, and comfortable skin protection and positioning wheelchair cushion designed specifically for kids! FDA UDI
Identifiers
- Catalog Number
- E2607 FDA UDI
- Primary DI / UDI-DI
- 00016958056259 FDA UDI
- FDA Product Code
- IMP FDA UDI
- GMDN Term
- Foam-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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foam-filled chair cushion
Jay Zip Cushion by Sunrise Medical (US) LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Foam-filled chair cushion.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sunrise Medical (US) LLC
Sources (2)
- FDA UDI 8aa23ead-9c1b-493c-b616-e7991997a1a7 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026