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Electric wheelchair (S7204/S7205)

by Dongguan Prestige Sporting Goods Co., Ltd.

510(k) K202632

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 NumberK202632 Date8 Apr 2021ClearedStatusActive

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  • Withdrawn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
ITI
Device Class
Class II
Regulation
21 CFR Part 890.3860
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

An electric wheelchair is a powered mobility device designed to assist individuals with limited mobility in moving independently. This device is classified as a powered wheelchair under FDA regulations and is intended for use in providing mobility support to users with physical impairments.

The device is supplied as a reusable medical device and is intended for use in home or institutional settings. It has received FDA 510(k) clearance (K202632) and is classified as a Class II medical device under regulation number 890.3860, with product code ITI and advisory committee designation in Physical Medicine.

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Questions

AI-generated answers, 23 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 electric wheelchair (S7204/S7205) intended for?

    The electric wheelchair (S7204/S7205) is intended to assist individuals with limited mobility in moving independently, providing mobility support in home or institutional settings as a powered mobility device for users with physical impairments.

  • Is the electric wheelchair (S7204/S7205) reusable or single-use?

    The electric wheelchair (S7204/S7205) is supplied as a reusable medical device, designed for repeated use over time in home or institutional environments, not for single-use disposal.

  • What regulatory clearance does the electric wheelchair (S7204/S7205) have?

    The electric wheelchair (S7204/S7205) has received FDA 510(k) clearance under submission number K202632 and is classified as a Class II medical device under regulation 890.3860 with product code ITI.