Skip to content

Flexicair Low Airloss Therapy Unit

by Support Systems Intl.

510(k) K920382

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920382 Date7 Apr 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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, 1 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 Flexicair Low Airloss Therapy Unit is a powered bed designed for flotation therapy, classified under the nomenclature for bed, flotation therapy, powered. It is intended to reduce pressure ulcers and manage patient positioning by distributing body weight across a larger surface area, thereby minimizing pressure points and promoting circulation. This device is specifically engineered for use in physical medicine settings, where patient mobility and comfort are critical.

This therapy unit is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K920382) with a classification of Class II. It is intended for use in clinical environments such as hospitals or rehabilitation centers, where it is connected to a power source for operation. The device adheres to regulatory standards outlined in 890.5170 and is manufactured by Support Systems International. No specific sterility requirements are noted, but standard hospital infection control protocols should be followed during use and maintenance.

Other devices from Support Systems Intl.