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Modified Chairs (Dental, Medical, and Podiatry)

by The Healthcare Group, Inc.

510(k) K902795

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 NumberK902795 Date25 Jul 1990ClearedStatusActive

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  • Withdrawn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
INO
Device Class
Class II
Regulation
21 CFR Part 890.3110
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

Modified Chairs (Dental, Medical, and Podiatry) are positioning chairs designed for use in dental, medical, and podiatry settings. These electric chairs are classified as Class II medical devices under regulation number 890.3110 and were found substantially equivalent through the traditional 510(k) pathway.

The device is supplied as a reusable electric chair for clinical use in physical medicine applications. It is manufactured by The Healthcare Group, Inc. and holds FDA 510(k) clearance under K902795, with multiple associated FEI and registration numbers as listed in the specifications.

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Questions

AI-generated answers, 26 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 Modified Chair used for?

    The Modified Chair is a positioning chair designed for use in dental, medical, and podiatry settings to support patient positioning during clinical procedures in physical medicine applications.

  • Is the Modified Chair reusable or single-use?

    The Modified Chair is supplied as a reusable electric chair intended for repeated clinical use, as indicated in its description as a reusable device for physical medicine applications.

  • How is the Modified Chair powered and operated?

    The Modified Chair is an electric chair, meaning it uses electrical power to adjust positioning, allowing for precise and effortless patient positioning in clinical environments.

  • What regulatory pathway was used for the Modified Chair's clearance?

    The Modified Chair received FDA 510(k) clearance through the traditional pathway, as specified by its clearance_type and decision_description indicating it was found substantially equivalent.

  • Who manufactures the Modified Chair and where is it located?

    The Modified Chair is manufactured by The Healthcare Group, Inc., located at 2601 S. Constitution Blvd., West Valley, UT 84119, United States.