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Permobil C300

by Permobil, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

4 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number17330818889420 UDI-DI Date12 Aug 2016ListedStatusListed GUDID: in commercial distribution

Recalls

4 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-1278-2012 FDA Not yet classified initiated 21 Feb 2012 on shared 510(k) K041219

    The fasteners used between June 3, 2011 and January 31, 2012 to attach the Permolock C3 pins to wheelchairs manufactured in the United States do not contain the required nylon ring, which allows for a more secure attachment.

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Permobil
Generic Name
Electric-motor-driven wheelchair, occupant-controlled
Model / Ref / Catalog
C300, K300 PS Junior
Primary DI / UDI-DI
17330818889420
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

Other devices from Permobil, Inc.

See all devices from Permobil, Inc. →

Properties

  • Over-the-Counter
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No