Q-Tel Rms (Rehabilitation Management System), Model 000503

• • Terminated Z-1757-2010 FDA Unclassified (pre-2012) ·initiated 30 Mar 2009 ·on shared 510(k) K003576

  28 stress and rehab treadmills manufactured between September 2006 and January 2009 may not have received adequate electrical safety testing prior to being shipped from the factory. If these components break down in the field, a patient or operator could be exposed to excess touch currents on the surface of the product. Because safety testing may not have allowed for complete evaluation of the el

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

510(k) Number

K003576 ↗

FDA Product Code

DSI

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Quinton Single Lumen Catheter

  Class II

  FDA 510(k) K893188 Active Cleared 8 Jun 1989

• Stainless Steel Guide Wire

  Class II

  FDA 510(k) K831839 Active Cleared 18 Jul 1983

• Medtrack Treadmill

  Class I

  FDA 510(k) K911751 Active Cleared 29 May 1991

• Patient by-Pass

  Class I

  FDA 510(k) K771422 Active Cleared 3 Jan 1978

• Quinton Lte Electrode

  Class II

  FDA 510(k) K810563 Active Cleared 17 Mar 1981

• Model 845T Imaging/Ergometer Table

  Class I

  FDA 510(k) K781500 Active Cleared 14 Sep 1978

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