Skip to content

Training Wheelchair

by Poirier S.A.

510(k) K840635

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 NumberK840635 Date27 Feb 1984ClearedStatusActive

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  • Withdrawn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
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.

A Training Wheelchair is a device classified as a Wheelchair, Special Grade, intended for use in physical medicine. It is a medical device designed to assist with mobility and training purposes.

The device was cleared by the FDA through the 510(k) process under K840635, with a decision of substantially equivalent issued on February 27, 1984. It is classified as Class II, product code IQC, and falls under regulation number 890.3880 with a medical specialty in Physical Medicine.

Other devices from Poirier S.A.

See all devices from Poirier S.A. →

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 Training Wheelchair used for?

    The Training Wheelchair is intended for use in physical medicine to assist with mobility and training purposes, as a Special Grade wheelchair designed to support patient movement during therapeutic or rehabilitative activities.

  • Who manufactures the Training Wheelchair and where are they located?

    The Training Wheelchair is manufactured by Poirier S.A., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States, as listed in the FDA 510(k) submission for device K840635.

  • How was the Training Wheelchair cleared for market release?

    The Training Wheelchair was cleared by the FDA through the traditional 510(k) process under submission K840635, with a determination of substantial equivalence issued on February 27, 1984, based on its classification as a Class II device under product code IQC.