Vectra (Intelect) Epr Ultrasound

• • Terminated Z-1636-2008 FDA Unclassified (pre-2012) ·initiated 28 Feb 2008

  Device may fail to administer therapy during use.

510(k) Number

K031116 ↗

FDA Product Code

IMI

Device Class

Class II

Regulation

21 CFR Part 890.5300

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

• 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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