Identity
- Trade Name
- WAFFLE FDA UDI
- Generic Name
- Air-filled bed mattress overlay FDA UDI
- Device Name
- 1025ECPW WAFFLE MATTTRSS PAD W/PMP & WDG - SNGL FDA UDI
- Model / Reference
- REV00 FDA UDI
- Description
- 1025ECPW WAFFLE MATTTRSS PAD W/PMP & WDG - SNGL FDA UDI
Identifiers
- Catalog Number
- 1025ECPW010 FDA UDI
- Primary DI / UDI-DI
- 10603354100074 FDA UDI
- FDA Product Code
- IKY FDA UDI
- GMDN Term
- Air-filled bed mattress overlay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5150 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
No
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
No
FDA UDI
Category: Air-filled bed mattress overlay
Explore the WAFFLE mattress pad, a innovative solution for pressure relief and comfort, designed to provide support and stability for individuals with disabilities or mobility issues. Made from a static-air-inflated pad, this device is lightweight, compact, and easy to use.
Similar devices
Also classified as Air-filled bed mattress overlay.
- SofCare — Stryker Corp. · Class II
- DuoGard — Stryker Corp. · Class II
- DALTON XCELL AIR MATTRESS — Dalton Medical Corp. · Class II
- SofCare — Stryker Corp. · Class II
- DALTON LOW AIR LOSS MATTRESS SYSTEM — Dalton Medical Corp. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- DALTON BARIATRIC LOW AIR LOSS MATTRESS SYSTEM — Dalton Medical Corp. · Class II
- APM Mattress — SIZEWISE RENTALS, L.L.C. · 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
- Ehob, Inc.
Sources (1)
- FDA UDI cba8c7ab-cd16-486a-95aa-a8468dea5abd 34 fields · synced Jun 28, 2026