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Invacare® Fdx® Power Wheelchair Ato_fdx-Mcg

by Invacare Corp. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841447198802 UDI-DI Date20 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-1138-2015 FDA Class II initiated 15 Jan 2015

    If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. Smoking, sparking, burning or fire may occur if a wire is repetitively pinched at the same place.

    • Terminated Z-1905-2012 FDA Class II initiated 6 Apr 2012

    Invacare Corporation decided to recall the product because of a potential risk of fire and serious injury. The post fuse assemblies could potentially have a short between the positive ring terminal and the terminal battery bracket which would create an alternate current path around the fuse.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Invacare® Fdx® Power Wheelchair
Generic Name
Electric-motor-driven wheelchair, occupant-controlled
Model / Ref / Catalog
ATO_FDX-MCG
Primary DI / UDI-DI
00841447198802
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

Cleared under the same submission (K991168)

Other devices from Invacare Corp.

See all devices from Invacare Corp. →

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