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Invacare® Tdx® Si Power Wheelchair Tdxsi-2

by Invacare Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

7 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 Number00841447198734 UDI-DI Date20 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

7 recalls · FDA

    • Terminated Z-1137-2015 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-2270-2013 FDA Class II initiated 4 Jun 2013

    Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks.

    • 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.

    • Terminated Z-1201-2012 FDA Not yet classified initiated 10 Feb 2012

    Invacare Corporation decided to recall the product because use of this actuator could result in reduced cross sectional current carrying area due to wear/chafing of the wires.

    • Terminated Z-0579-2010 FDA Unclassified (pre-2012) initiated 15 Sep 2009

    For some Invacare chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may do one or more of the following: (1) veer to one side; (2) rock forward onto its front riggings; (3) drive in an unintended circular motion; and/or (4) fall forward or to one side. In these cases there is a risk to injury for

    • Terminated Z-0930-2009 FDA Unclassified (pre-2012) initiated 27 Nov 2007

    Invacare has become aware that on some chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may veer to one side or it may rock forward onto its front riggings.

    • Terminated Z-0966-2007 FDA Unclassified (pre-2012) initiated 19 Mar 2007

    Software error may permit the chair to recline too far.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Invacare® Tdx® Si Power Wheelchair
Generic Name
Electric-motor-driven wheelchair, occupant-controlled
Model / Ref / Catalog
TDXSI-2
Primary DI / UDI-DI
00841447198734
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

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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