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Comfort-Aire

by Advanced Air Dynamics, Inc.

510(k) K905126

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 NumberK905126 Date19 Dec 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  • Withdrawn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)

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, 28 Sep 2026

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

This device is a powered flotation therapy bed, as defined in the device type and openfda device_name fields. It is designed for use in physical medicine settings to provide therapeutic flotation support.

The device is supplied as a reusable system and has received FDA 510(k) clearance under K905126. It is classified as a Class II medical device and is intended for use in accordance with its authorization and specifications.

Questions

AI-generated answers, 28 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 COMFORT-AIRE device used for?

    The COMFORT-AIRE is a powered flotation therapy bed designed to provide therapeutic flotation support in physical medicine settings, as defined by its device name and intended use for flotation-based therapy.

  • Is the COMFORT-AIRE device reusable or single-use?

    The COMFORT-AIRE is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and maintenance, not for single-use disposal.

  • What regulatory clearance does the COMFORT-AIRE have?

    The COMFORT-AIRE received FDA 510(k) clearance under submission number K905126, which is explicitly stated in the device data as its authorization pathway.

  • What class of medical device is the COMFORT-AIRE?

    The COMFORT-AIRE is classified as a Class II medical device, as indicated in the device data under its classification and regulatory details.

  • Who manufactures the COMFORT-AIRE device?

    The COMFORT-AIRE is manufactured by Advanced Air Dynamics, Inc., as listed in the manufacturer field of the device data.