Permobil Powered Wheelchair 1280

510(k) K991658

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 closed

Documents

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Abbreviated	NumberK991658	Date8 Oct 1999Cleared	StatusActive

5 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.
- Terminated Z-0834-03 FDA Unclassified (pre-2012) initiated 7 Mar 2003
One of the wheelchair motors needed a grounding strap to ensure that the motors are at the same voltage potential as the chassis of the wheelchair.
- Terminated Z-0671-03 FDA Unclassified (pre-2012) initiated 1 Jan 2003 on shared 510(k) K991658
Incidents were reported where a drive wheel has come off its motor axle, due either to loosening of the wheel bolt or a broken wheel bolt.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)