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Poirier Variable Wheelchair

by Poirier S.A.

510(k) K840234

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 NumberK840234 Date27 Feb 1984ClearedStatusActive

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  • Withdrawn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
IQC
Device Class
Class II
Regulation
21 CFR Part 890.3880
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 Poirier Variable Wheelchair is a Wheelchair, Special Grade, designed for mobility assistance in physical medicine settings. It features adjustable components to accommodate varying user needs, including height and positioning adjustments, ensuring adaptability for different users and environments. This device is classified as a Class 2 medical device under FDA regulations, intended for long-term use by individuals requiring mobility support.

This wheelchair is supplied as a reusable, non-sterile device intended for clinical use in physical medicine rehabilitation settings. It is regulated under FDA product code IQC and cleared through the Traditional 510(k) pathway, with clearance granted on February 27, 1984. No specific MRI safety or sterility requirements are noted in the regulatory data, and its design does not include single-use components. Storage and maintenance instructions are not provided in the available specifications.

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Questions

AI-generated answers, 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.

  • What is the Poirier Variable Wheelchair designed for?

    The Poirier Variable Wheelchair is a Class 2 medical device intended for long-term mobility assistance in physical medicine rehabilitation settings. Its adjustable components—such as height and positioning—allow it to adapt to varying user needs and clinical environments, ensuring flexibility for patients requiring sustained support.

  • Is the Poirier Variable Wheelchair reusable or single-use?

    This wheelchair is supplied as a reusable device, not intended for single-use. It is designed for clinical settings where durability and repeated use are required, though no specific sterility requirements are noted in the regulatory data.

  • What regulatory pathway was used for FDA clearance?

    The Poirier Variable Wheelchair was cleared through the Traditional 510(k) pathway, with a decision of substantial equivalence (SESE) granted by the FDA’s Physical Medicine Advisory Committee on February 27, 1984. The clearance was filed under product code IQC.

  • Are there any special storage or maintenance instructions?

    The available specifications do not include detailed storage or maintenance instructions for the Poirier Variable Wheelchair. Users should follow general clinical practices for reusable mobility aids, ensuring proper cleaning and inspection to maintain functionality and hygiene.

  • Does this wheelchair have MRI compatibility?

    The regulatory data does not specify MRI safety information for the Poirier Variable Wheelchair. Clinicians should verify compatibility with their MRI systems before use, as no explicit MRI-safe labeling is provided.