Identity
- Trade Name
- Xtra-Comfort FDA UDI
- Generic Name
- Water-filled chair cushion FDA UDI
- Device Name
- Water Pillow (V2) FDA UDI
- Model / Reference
- CSH1065WHT FDA UDI
- Description
- Water Pillow (V2) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810041983923 FDA UDI
- FDA Product Code
- IQK FDA UDI
- GMDN Term
- Water-filled chair cushion FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 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
No
FDA UDI
Category: Water-filled chair cushion
Xtra-Comfort by Vive Health Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Water-filled chair cushion.
- Jay Fusion — Sunrise Medical (US) LLC · 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
- Vive Health Llc
Sources (1)
- FDA UDI 5c2d1b30-2f14-46c9-ba7a-d6dfb40e45e7 33 fields · synced May 30, 2026