Identity
- Trade Name
- K-1 DERMA-KARE FDA UDI
- Generic Name
- Alternating-pressure bed mattress overlay system FDA UDI
- Device Name
- K-1 Alternating Pressure Control Unit with UK or EU power cord FDA UDI
- Model / Reference
- K-1 220V FDA UDI
- Description
- K-1 Alternating Pressure Control Unit with UK or EU power cord FDA UDI
Identifiers
- Catalog Number
- K-1 FDA UDI
- Primary DI / UDI-DI
- 00817012023404 FDA UDI
- FDA Product Code
- FNM FDA UDI
- GMDN Term
- Alternating-pressure bed mattress overlay system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5550 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Alternating-pressure bed mattress overlay system
K-1 Derma-Kare by Kap Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alternating-pressure bed mattress overlay system.
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- PressureGuard® — Span-America Medical Systems, Inc. · Class II
- Progressa® Surface — HILL-ROM, INC. · Class II
- Alternate Cair Plus — Joerns Healthcare · Class II
- PressureGuard® — Span-America Medical Systems, Inc. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Kap Medical
Sources (1)
- FDA UDI ba0c06ee-f16d-49ad-99d3-6b3fb9f15ab2 35 fields · synced May 30, 2026