Identity
- Trade Name
- Jay X2 FDA UDI
- Generic Name
- Gel-filled chair cushion FDA UDI
- Device Name
- The JAY X2® is a lightweight, maintenance-free, fluid wheelchair cushion with a reduced profile that is designed to provide stability and pressure relief to active clients. Using elements from the JAY Xtreme and Active cushions, the X2 combines JAY’s time-tested designs with its latest technologies. FDA UDI
- Model / Reference
- X2 FDA UDI
- Description
- The JAY X2® is a lightweight, maintenance-free, fluid wheelchair cushion with a reduced profile that is designed to provide stability and pressure relief to active clients. Using elements from the JAY Xtreme and Active cushions, the X2 combines JAY’s time-tested designs with its latest technologies. FDA UDI
Identifiers
- Catalog Number
- E2622 FDA UDI
- Primary DI / UDI-DI
- 00016958056716 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 X2 by Sunrise Medical (US) LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gel-filled chair cushion.
- CUSHION T-GEL+ 16INX16IN W/ INSERT — AliMed, LLC · Class I
- CUSHION CHKBRD TGEL TFM SSI, 18 INX 16 IN RIPSTOP NYLON COVER — AliMed, LLC · Class I
- Action® — Action Products, Inc. · Class I
- Ever-Soft Gel Foam Cushion — Dynarex Corp. · Class I
- Drive — Drive Devilbiss Healthcare · Class I
- Everest & Jennings — GF Health Products, Inc · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sunrise Medical (US) LLC
Sources (1)
- FDA UDI af63b9f9-582f-4c33-97cc-ff9d8e8a3caf 34 fields · synced Jun 9, 2026