Mark IV Floatation Therapy Bed

FDA 510(k) K901890 · Hydrothermic Floatation Systems, Inc.

Substantially Equivalent

510(k) numberK901890

Submission

Device name
Mark IV Floatation Therapy Bed
Applicant
Hydrothermic Floatation Systems, Inc.
Los Angeles, CA, US
Received
April 26, 1990
Decision date
May 7, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

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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
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K943433Total Contact Seat Ripple SystemIOQ · Traditional Numotech, Inc.07/31/1995SE
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Questions and answers

When was Mark IV Floatation Therapy Bed cleared by the FDA?

Mark IV Floatation Therapy Bed (K901890) received a 510(k) decision of Substantially Equivalent on May 7, 1990, 11 days after the submission was received.

What is the product code of K901890?

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