T-Pump Localized Temperature Therapy Pump

• • Terminated Z-1013-2018 FDA Class III ·initiated 7 Nov 2017

  The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for normothermia maintenance to the Indications for Use statement.

510(k) Number

K073675 ↗

FDA Product Code

ILO

Device Class

Class II

Regulation

21 CFR Part 890.5720

Advisory Committee

Physical Medicine

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, 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

• Air-Flo Alternating Pressure Pad System

  Class II

  FDA 510(k) K780906 Active Cleared 10 Aug 1978

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