Skip to content

Micro-Temp Pumps & Micro-Temp Pads

by Seabrook Medical Systems, Inc.

510(k) K843146

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843146 Date17 Aug 1984ClearedStatusActive

Recalls

2 recalls · FDA

    • 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.

    • Terminated Z-0671-05 FDA Unclassified (pre-2012) initiated 18 Jan 2005

    There is the potential that the power switch assembly can dislodge from the cabinet during use.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ILO
Device Class
Class II
Regulation
21 CFR Part 890.5720
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a Pack, Hot Or Cold, Water Circulating, as defined in the device type and definition from the nomenclature authority. It consists of a pump, connecting hose, and a vinyl pad designed to circulate water for localized heat or cold therapy.

The device is supplied as a system including the pump, hose, and vinyl pad. It is intended for use in physical medicine settings and provides consistent temperature control with safety features such as over-temperature protection and low water cut-off. The device received FDA 510(k) clearance under K843146 on August 17, 1984, and is classified as a Class II medical device.

Other devices from Seabrook Medical Systems, Inc.

See all devices from Seabrook Medical Systems, Inc. →