Clensicair Low Airloss Hydrotherapy

FDA 510(k) K941610 · Support Systems Intl.

Substantially Equivalent

510(k) numberK941610

Submission

Device name
Clensicair Low Airloss Hydrotherapy
Applicant
Support Systems Intl.
Charleston, SC, US
Received
March 31, 1994
Decision date
February 10, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IOQ – Bed, Flotation Therapy, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5170
Specialty
Physical Medicine

Other 510(k)s with product code IOQ

510(k)DeviceApplicantDecision
K143414Hill-Rom Wireless Connectivity ModuleIOQ · Traditional Hill-Rom03/10/2015SE
K122473Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2IOQ · Traditional Hill-Rom06/03/2013SE
K973624Nurse's Aid Patient Rotation SystemIOQ · Traditional Air Med Assist Products01/21/1998SE
K970364AIRTEC2 Low Air Loss Therapy BedIOQ · Traditional Apex Metal, Inc.11/17/1997SE
K970363Hydrotec Low Air Loss Therapy BedIOQ · Traditional Apex Metal, Inc.11/17/1997SE
K970636Totalcare., Modular Therapy System (MTS)IOQ · Traditional Hill-Rom, Inc.08/26/1997SE
K964873Silkair Low Airloss TherapyIOQ · Traditional Hill-Rom, Inc.07/03/1997SE
K970295Flexicair Exlipse PlusIOQ · Traditional Hill-Rom, Inc.05/16/1997SE
K943433Total Contact Seat Ripple SystemIOQ · Traditional Numotech, Inc.07/31/1995SE
K951001Flexicair ExlipseIOQ · Traditional Hill-Rom, Inc.06/27/1995SE

More from Hill-Rom, Inc.

510(k)DeviceDecision
K940662I-5000IOQ · Traditional 06/15/1994SE
K922973Restcue CCIOQ · Traditional 07/30/1992SE
K920382Flexicair Low Airloss Therapy UnitIOQ · Traditional 04/07/1992SE
K920112Clinitron C-IiINX · Traditional 01/24/1992SE

Questions and answers

When was Clensicair Low Airloss Hydrotherapy cleared by the FDA?

Clensicair Low Airloss Hydrotherapy (K941610) received a 510(k) decision of Substantially Equivalent on February 10, 1995, 316 days after the submission was received.

What is the product code of K941610?

The FDA product code is IOQ – Bed, Flotation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5170.