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C350 Powered Wheelchair

by Permobil AB

510(k) K071650

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 NumberK071650 Date12 Sep 2007ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-3178-2018 FDA Class II initiated 15 Aug 2018

    This correction decision has been made because of a potential failure of one or both backrest bars providing back support. If one or both back support telescoping bars fail the user could fall back leading to a potential injury.

  • 2 recalls, same reason

    • Terminated Z-0006-2018 FDA Class II initiated 1 Sep 2017
    • Terminated Z-0005-2018 FDA Class II initiated 1 Sep 2017

    There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base.

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  • Withdrawn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

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