Vectra Transportable Combo and Stim (Specialty Line Dealers); Intelect Transportable Combo and Stim (General Line Dealer

• • Terminated Z-1639-2008 FDA Unclassified (pre-2012) ·initiated 28 Feb 2008 ·on shared 510(k) K040285

  Device may fail to administer therapy during use.

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

510(k) Number

K040285 ↗

FDA Product Code

IMG

Models / Variants

Vectra Transportable Combo And Stim (Specialty Line Dealers)

Intelect Transportable Combo And Stim (General Line Dealer

Device Class

Class II

Regulation

21 CFR Part 890.5860

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Triton/Tru-Trac/Tx Traction Devices

  Class II

  FDA 510(k) K051938 Active Cleared 21 Sep 2005

• Kin-Com Asymmetrical Back System

  Class II

  FDA 510(k) K911805 Active Cleared 3 Jul 1991

• Vectra Stim Models 200 and 400

  Class II

  FDA 510(k) K982321 Active Cleared 1 Feb 1999

• Ist-200 Intersegmental Traction Table

  Class II

  FDA 510(k) K900304 Active Cleared 11 Apr 1990

• Intelect Swd 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601

  Class II

  FDA 510(k) K083433 Active Cleared 18 Mar 2009

• Electro-Goniometer

  Class I

  FDA 510(k) K812908 Active Cleared 24 Nov 1981

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