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MA012 Aluminum Wheelchair, MS019 Steel Wheelchair

by Sichuan Ast Medical Equipment Co., Ltd.

510(k) K231750

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231750↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK231750 Date15 Aug 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
IOR
Device Class
Class I
Regulation
21 CFR Part 890.3850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Ma012 Aluminum Wheelchair, Ms019 Steel Wheelchair is a mechanical wheelchair. It is a device class 1 medical device used in physical medicine.

The device is supplied by Sichuan Ast Medical Equipment Co., Ltd. and has received FDA 510k clearance under approval number K231750, with a regulation number of 890.3850. The device is substantially equivalent and has a traditional clearance type.

Other devices from Sichuan Ast Medical Equipment Co., Ltd.

Questions

AI-generated answers, 28 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 MA012 Aluminum Wheelchair used for?

    The MA012 Aluminum Wheelchair is used in physical medicine, providing a mechanical means of mobility for patients.

  • Is the MA012 Aluminum Wheelchair sterile?

    The device data does not specify the sterility of the MA012 Aluminum Wheelchair, it is recommended to consult the manufacturer's instructions for use.

  • What is the regulatory status of the MA012 Aluminum Wheelchair?

    The MA012 Aluminum Wheelchair has received FDA 510k clearance under approval number K231750, with a regulation number of 890.3850, and is substantially equivalent to a predicate device.