Model 4000 Alternating Pressure Pump and Pad

FDA 510(k) K891259 · Diamond Medical Equipment, Inc.

Substantially Equivalent

510(k) numberK891259

Submission

Device name
Model 4000 Alternating Pressure Pump and Pad
Applicant
Diamond Medical Equipment, Inc.
Jamaica, NY, US
Received
March 8, 1989
Decision date
November 17, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

510(k)DeviceApplicantDecision
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
K902520Air Plus NebulizerBTI · Traditional 03/04/1991SE
K883188T.E.N.S. Unit Sigma & TX-3GZJ · Traditional 12/16/1988SE

Questions and answers

When was Model 4000 Alternating Pressure Pump and Pad cleared by the FDA?

Model 4000 Alternating Pressure Pump and Pad (K891259) received a 510(k) decision of Substantially Equivalent on November 17, 1989, 254 days after the submission was received.

What is the product code of K891259?

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