Cleared Traditional

K901890 - MARK IV FLOATATION THERAPY BED

K901890 is an FDA 510(k) clearance for MARK IV FLOATATION THERAPY BED, manufactured by Hydrothermic Floatation Systems, Inc.. The device is a Class 2 Physical Medicine device with product code IOQ cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K901890 · Hydrothermic Floatation Systems, Inc. · Physical Medicine device
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May 1990
Decision
11d
Days
Class 2
Risk

K901890 is an FDA 510(k) clearance for the MARK IV FLOATATION THERAPY BED. Classified as Bed, Flotation Therapy, Powered (product code IOQ), Class II - Special Controls.

Submitted by Hydrothermic Floatation Systems, Inc. (Los Angeles, US). The FDA issued a Cleared decision on May 7, 1990 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5170 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hydrothermic Floatation Systems, Inc. devices

FDA 510(k) Submission Details - K901890

510(k) Number K901890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1990
Decision Date May 07, 1990
Days to Decision 11 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 115d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IOQ Device Classification - Class 2, Special Controls

Product Code IOQ Bed, Flotation Therapy, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IOQ Bed, Flotation Therapy, Powered

All 17
Devices cleared under the same product code (IOQ) and FDA review panel - the closest regulatory comparables to K901890.
TURBO
K912854 · Kinetic Concepts, Inc. · Dec 1991
CLA-1400 SYSTEM
K914851 · Gaymar Industries, Inc. · Nov 1991
HAZEL
K912855 · Kinetic Concepts, Inc. · Sep 1991
MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE
K875321 · Kinetic Concepts, Inc. · Jan 1988
ROTATION AIR FLUIDIZED BED/DELTA
K864232 · Kinetic Concepts, Inc. · Dec 1986