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Permobil M5

by Permobil, Inc.

Permobil M5 is an electric-motor-driven wheelchair (FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Permobil, Inc., cleared under FDA 510(k) K123290 on 17 Apr 2013 and listed in FDA GUDID since 1 Mar 2017 (UDI-DI 17330818334562), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K123290

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number17330818334562 UDI-DI Date1 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123290 Date17 Apr 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123290 decided 17 Apr 2013 Active
  • FDA GUDID UDI-DI 17330818334562 listed 1 Mar 2017 Listed

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-2805-2026 FDA Class II initiated 19 Jun 2025

    This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, and may create an unstable condition in certain circumstances.

    • Ongoing Z-2795-2026 FDA Class II initiated 29 Feb 2024

    This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the user to fall from the wheelchair or the wheelchair to tip over,

    • 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.

Timeline

5 dated events

  1. Cleared FDA 510(k) K123290
  2. Listed FDA GUDID 17330818334562
  3. Recall initiated FDA recalls Z-3178-2018
  4. Recall initiated FDA recalls Z-2795-2026
  5. Recall initiated FDA recalls Z-2805-2026

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Permobil
Generic name
Electric-motor-driven wheelchair, occupant-controlled
Model / reference
M5
Primary DI / UDI-DI
17330818334562
510(k) Number
FDA product code
ITI
GMDN term
Electric-motor-driven wheelchair, occupant-controlled
Device class
Class II
Regulation number
890.3860
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electric-motor-driven wheelchair, occupant-controlled

Cleared under the same submission (K123290)

Similar devices in this category

Other devices filed under Electric-motor-driven wheelchair, occupant-controlled.

Other devices from Permobil, Inc.

  • Permobil C300

    Class II

  • Permobil M Corpus VS

    Class II

  • Permobil F3

    Class II

  • Permobil F5

    Class II

See all devices from Permobil, Inc. →

Properties

  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)