PRO-2000 Low Air Loss Therapy Bed

FDA 510(k) K926403 · Ch Administration, Inc.

Substantially Equivalent

510(k) numberK926403

Submission

Device name
PRO-2000 Low Air Loss Therapy Bed
Applicant
Ch Administration, Inc.
Dallas, TX, US
Received
December 21, 1992
Decision date
July 30, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FNM – Mattress, Air Flotation, Alternating Pressure
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5550
Specialty
General Hospital

Other 510(k)s with product code FNM

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K973169Pressure Guard Site Select (a)FNM · Traditional Span-America Medical Systems, Inc.02/20/1998SE
K974319Mighty AirFNM · Traditional Wheelchairs of Kansas01/22/1998SE
K972022ZAK-2000FNM · Traditional Cardio Systems, Inc.01/22/1998SE
K974070PHYSIO/1000FNM · Traditional Physio Designs, Inc.01/06/1998SE
K972549SimpulseFNM · Traditional Kinetic Concepts, Inc.11/18/1997SE
K970081Super Air 9000 Alternating Air Floatation Mattress SystemFNM · Traditional Cathay Consolidated, Inc.11/07/1997SE
K955243BariairFNM · Traditional Kinetic Concepts, Inc.10/23/1997SE
K970468KT Air BedFNM · Traditional Kinetic Concepts, Inc.09/05/1997SE
K965207Rid-Decube IIFNM · Traditional Skin Care Management, Inc.08/21/1997SE
K972153Alternating Pressure Air Flotation MattressFNM · Traditional Decubiti Concepts, Inc.07/31/1997SE

More from Decubiti Concepts, Inc.

510(k)DeviceDecision
K953196Cardio-Systems Pro-OpFNM · Traditional 11/08/1995SE
K926402Comfort Care Low Air Loss Therapy BedINX · Traditional 03/24/1993SE

Questions and answers

When was PRO-2000 Low Air Loss Therapy Bed cleared by the FDA?

PRO-2000 Low Air Loss Therapy Bed (K926403) received a 510(k) decision of Substantially Equivalent on July 30, 1993, 221 days after the submission was received.

What is the product code of K926403?

The FDA product code is FNM – Mattress, Air Flotation, Alternating Pressure, a Class II (moderate risk) device regulated under 21 CFR 880.5550.