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Mark IV Flotation Therapy Bed

by Hydrothermic Floatation Systems, Inc.

510(k) K901890

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK901890 Date7 May 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Mark IV Floatation Therapy Bed
510(k) Number
FDA Product Code
IOQ
Device Class
Class II
Regulation
21 CFR Part 890.5170
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A flotation therapy bed is a powered bed designed for therapeutic flotation treatment. It provides a buoyant, water-supported surface to reduce pressure on the body and promote relaxation and therapeutic benefits.

This device is supplied as a reusable, non-sterile system intended for use in clinical or therapeutic settings such as physical medicine facilities. It is not MRI safe unless specifically tested and labeled as such, and it operates under FDA 510(k) clearance K901890 with product code IOQ and regulation number 890.5170.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Mark IV Flotation Therapy Bed used for?

    The Mark IV Flotation Therapy Bed is designed for therapeutic flotation treatment, providing a buoyant, water-supported surface to reduce pressure on the body and promote relaxation and therapeutic benefits in clinical or therapeutic settings such as physical medicine facilities.

  • Is the Mark IV Flotation Therapy Bed sterile or single-use?

    The device is supplied as a reusable, non-sterile system, meaning it is intended for multiple uses after appropriate cleaning and is not provided in a sterile condition for single-use applications.

  • What regulatory pathway was used for the Mark IV Flotation Therapy Bed?

    The Mark IV Flotation Therapy Bed received FDA 510(k) clearance under submission number K901890, with product code IOQ and regulation number 890.5170, indicating it was found substantially equivalent to a legally marketed predicate device.