Medi-Therm (Mta-5900) & Detachable Hoses

• • Terminated Z-2058-2017 FDA Class II ·initiated 29 Mar 2017

  The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to view water temperature, and then switched back to "Automatic" mode.

• • Terminated Z-0933-2014 FDA Class II ·initiated 27 Dec 2013

  Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature display while the unit is in Auto mode. While in Auto mode, only the patient temperature is displayed along with the set point. The water display will be blank during Auto mode. If the user wants to see the water temperature displayed and switches out of Auto mode to Manual mode, then back to

510(k) Number

K912051 ↗

FDA Product Code

DWJ

Device Class

Class II

Regulation

21 CFR Part 870.5900

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900

  Class II

  FDA 510(k) K100585 Active Cleared 20 Jan 2011

• Sequential Pressure Cuff

  Class II

  FDA 510(k) K771083 Active Cleared 21 Jul 1977

• Sof. Press Epc 51 System

  Class II

  FDA 510(k) K963067 Active Cleared 28 Jan 1997

• T-Pump Localized Temperature Therapy Pump

  Class II

  FDA 510(k) K073675 Active Cleared 8 May 2008

• T-Pump, Temperature - Therapy Pump

  Class II

  FDA 510(k) K760804 Active Cleared 15 Oct 1976

• Lifestyle Sof. Care Gel Chair Cushion

  Class I

  FDA 510(k) K882012 Active Cleared 23 May 1988

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