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Airhythm Healthcare Bed

by Healthcare Designs

510(k) K935837

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK935837 Date21 Jun 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
FNL
Device Class
Class II
Regulation
21 CFR Part 880.5100
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The AirRhythm Healthcare Bed is a hospital bed designed for adjustable positioning and powered operation, intended for use in general hospital settings. It falls under the classification of an adjustable, electrically powered medical bed, providing support and mobility for patients in various care environments.

This bed is supplied as a reusable, non-sterile medical device and is classified under FDA product code FNL. It was granted 510(k) clearance (K935837) by the FDA in 1994 under the Traditional 510(k) review pathway, with a decision of Substantially Equivalent. No MRI safety or sterility requirements are specified in the available data.

Questions

AI-generated answers, 19 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 types of care environments is the AirRhythm Healthcare Bed intended for, and how does its adjustable design support patient needs?

    The AirRhythm Healthcare Bed is specifically designed for general hospital settings, providing adjustable positioning and powered operation to support patient mobility and comfort. Its adjustable features allow for varied patient positions, which can aid in mobility assistance, pressure relief, and access to care—making it suitable for acute care, rehabilitation, or long-term hospital stays where patient positioning is critical.

  • Is the AirRhythm Healthcare Bed meant for single-use or can it be reused in a clinical setting?

    The AirRhythm Healthcare Bed is supplied as a reusable device, not intended for single-use. Since it is non-sterile, it is meant to be cleaned and reused between patients in a hospital environment, following standard infection control protocols.

  • What regulatory pathway was followed for the FDA clearance of this bed, and what does that mean for its use in hospitals?

    The AirRhythm Healthcare Bed received FDA clearance through the Traditional 510(k) review pathway, determined to be *substantially equivalent* to a predicate device. This means the FDA evaluated it against an existing, legally marketed bed and found it to have similar intended use and technological characteristics, ensuring it meets safety and effectiveness standards for use in general hospital settings.

  • How should the AirRhythm Healthcare Bed be stored, and are there any special considerations for its maintenance?

    The AirRhythm Healthcare Bed is non-sterile and reusable, so it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its components. Since it is electrically powered, it should be kept in a location where power supply and electrical safety protocols are maintained. Regular maintenance, including cleaning and inspection of mechanical/electrical parts, is recommended to ensure safe and reliable operation.