9TH Wave Models 500 & 550 Low Air Loss Systems

FDA 510(k) K963620 · 9th Wave, Inc.

Substantially Equivalent

510(k) numberK963620

Submission

Device name
9TH Wave Models 500 & 550 Low Air Loss Systems
Applicant
9th Wave, Inc.
Mt Pleasant, SC, US
Received
September 10, 1996
Decision date
January 7, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

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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
K9636779TH Wave Model 200 Alternating Pressure PadFNM · Traditional 11/26/1996SE
K9636269TH Wave Models 400 & 450 Alternating Pressure MattressFNM · Traditional 11/26/1996SE

Questions and answers

When was 9TH Wave Models 500 & 550 Low Air Loss Systems cleared by the FDA?

9TH Wave Models 500 & 550 Low Air Loss Systems (K963620) received a 510(k) decision of Substantially Equivalent on January 7, 1997, 119 days after the submission was received.

What is the product code of K963620?

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