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

• • Terminated Z-0121-2016 FDA Class II ·initiated 21 Aug 2015

  Overheating and burning of the wire insulation inside the applicator.

510(k) Number

K083433 ↗

FDA Product Code

IMJ

Models / Variants

Intelect Swd 100, Model 1600

Senior Solutions Shortwave Diathermy, Model 1601

Device Class

Class II

Regulation

21 CFR Part 890.5290

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

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

  Class II

  FDA 510(k) K040285 Active Cleared 12 Apr 2004

• Electro-Goniometer

  Class I

  FDA 510(k) K812908 Active Cleared 24 Nov 1981

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