Triton

• 2 recalls, same reason

  • Terminated Z-1215-03 FDA Unclassified (pre-2012) ·initiated 30 May 2003
  • Terminated Z-1210-03 FDA Unclassified (pre-2012) ·initiated 30 May 2003 ·on shared 510(k) K801643

  Product contains an improper bracket for the transducer.

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

510(k) Number

K801643 ↗

FDA Product Code

INW

Device Class

Class I

Regulation

21 CFR Part 890.3750

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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  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

• 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

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