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Water Flotation Bed 800/TC/H

by Western Medical, Ltd.

510(k) K840881

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 NumberK840881 Date18 Jul 1984ClearedStatusActive

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  • Withdrawn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
Water Floation Bed 800/Tc/H
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, 6 Oct 2026

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

The Water Flotation Bed 800/TC/H is a powered flotation therapy bed, equipped with a mattress that contains a large volume of constantly moving water. It is a device used for medical purposes, specifically for treating or preventing bedsores, treating severe or extensive burns, and aiding circulation. The mattress may be electrically heated.

The Water Flotation Bed 800/TC/H is supplied with FDA 510K authorization. It is classified as a class 2 device, with a product code of IOQ and a regulation number of 890.5170. The device is used in the field of physical medicine and has been registered with the FDA with the registration numbers listed. The device is available with the specified model number 800/TC/H.

Other devices from Western Medical, Ltd.

Questions

AI-generated answers, 6 Oct 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 Water Flotation Bed 800/TC/H used for?

    The Water Flotation Bed 800/TC/H is used for medical purposes, specifically for treating or preventing bedsores, treating severe or extensive burns, and aiding circulation.

  • Is the Water Flotation Bed 800/TC/H supplied with heating functionality?

    Yes, the mattress of the Water Flotation Bed 800/TC/H may be electrically heated.

  • What is the regulatory status of the Water Flotation Bed 800/TC/H?

    The Water Flotation Bed 800/TC/H is supplied with FDA 510K authorization and is classified as a class 2 device.