K-4 D³x K-4B54
by Kap Medical
K-4 D³x K-4B54 is a low-air-loss bed (FDA Class II; FDA product code FNM, Mattress, Air Flotation, Alternating Pressure) made by Kap Medical, listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00817012020991), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817012020991 | Date19 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00817012020991
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- K-4 D³x
- Generic name
- Low-air-loss bed
- Model / Ref / Catalog
- K-4B54
- Primary DI / UDI-DI
- 00817012020991
- FDA product code
- FNM
- GMDN term
- Low-air-loss bed
- Device class
- Class II
- Regulation number
- 880.5550
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FNM (Mattress, Air Flotation, Alternating Pressure).
- AUTO TURNER by George J. Kamilar
- Model 700 Low Pressure Mattress by SURGICAL DESIGN, INC.
- Pegasus Biwave System by Pegasus Airwave, Inc.
- P/2000 by Plexus Medical
- Unit-Matt 5000 Pressure Relief System by United Medical Equipment, Inc.
- The Lotecon Personal Care System by Lotecon, Inc.
- PRO-2000 Low Air Loss Therapy Bed by Ch Administration, Inc.
- 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD by 9th Wave, Inc.
- American Aircare System by American Hamilton
- LAKE STAGEZERO(TM) AIR FLOTATION BED by Lake Medical Products, Inc.