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Extentrac Elite M100

by Advanced Back Technologies

Extentrac Elite M100 is a Class II device made by Advanced Back Technologies, cleared under FDA 510(k) K031996 on 23 Jul 2004 and listed in FDA GUDID since 6 Nov 2019 (UDI-DI B727M100), active as of 23 Oct 2026. 2 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

None ongoing

2 closed

Documents

510(k) K031996

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 NumberB727M100 UDI-DI Date6 Nov 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK031996 Date23 Jul 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K031996 decided 23 Jul 2004 Active
  • FDA GUDID UDI-DI B727M100 listed 6 Nov 2019 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1717-2015 FDA Class II initiated 13 May 2015
    • Terminated Z-1718-2015 FDA Class II initiated 13 May 2015

    Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs

Timeline

4 dated events

  1. Cleared FDA 510(k) K031996
  2. Recall initiated FDA recalls Z-1717-2015
  3. Recall initiated FDA recalls Z-1718-2015
  4. Listed FDA GUDID B727M100

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Extentrac Elite
Generic name
Programmable powered traction system
Model / reference
M100
Primary DI / UDI-DI
B727M100
510(k) Number
FDA product code
ITH
GMDN term
Programmable powered traction system
Device class
Class II
Regulation number
890.5900
GUDID distribution status
In Commercial Distribution

Related devices

Category: Programmable powered traction system

Similar devices

Other devices filed under FDA product code ITH (Equipment, Traction, Powered).

Other devices from Advanced Back Technologies

  • Extentrac Elite

    Class II

  • Extentrac

    Class II

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)