Electri-Cool(Tm) Liquid-Circulat. Thermal Therapy

• • Terminated Z-1129-2015 FDA Class II ·initiated 7 Jan 2015

  Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.

510(k) Number

K902269 ↗

FDA Product Code

ILO

Device Class

Class II

Regulation

21 CFR Part 890.5720

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Tropicair Convective Warming Blankets

  Class II

  FDA 510(k) K952086 Active Cleared 6 Sep 1995

• Micro-Temp Pumps & Micro-Temp Pads

  Class II

  FDA 510(k) K843146 Active Cleared 17 Aug 1984

• Tropicair Convective Waring System

  Class II

  FDA 510(k) K946196 Active Cleared 6 Sep 1995

• Cool-Aid

  Class II

  FDA 510(k) K931203 Active Cleared 22 Feb 1994

• Golden Thermal(R)

  Class II

  FDA 510(k) K914182 Active Cleared 18 Oct 1991

• Ecmo-Temp (Tm) Blood Warming Device

  Class II

  FDA 510(k) K873699 Active Cleared 22 Dec 1987

See all devices from Seabrook Medical Systems, Inc. →

• What is the ELECTRI-COOL(TM) Liquid-Circulating Thermal Therapy device used for?

  It is designed for use in physical medicine applications where hot or cold thermal therapy is indicated, providing controlled temperature therapy through water circulation in a reusable pack system.

• How is the ELECTRI-COOL(TM) device supplied and is it reusable?

  The device is supplied as a reusable system, meaning it is intended for multiple uses after proper cleaning and maintenance, not as a single-use disposable product.

• What regulatory pathway was used for the ELECTRI-COOL(TM) device and what is its product code?

  The device received FDA 510(k) clearance through a traditional submission process and is classified under product code ILO, which corresponds to packs, hot or cold, water circulating.