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Hot/Ice Dual Function Equipment

by Thermo Temp, Inc.

510(k) K871962

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK871962 Date26 Jun 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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, 24 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 Hot/Ice Dual Function Equipment is a water circulating pack used for thermal therapy. It is designed to provide either hot or cold treatment as required by the user.

This device is authorized under FDA 510(k) clearance K871962. It is classified under the physical medicine specialty and is regulated as a water circulating hot or cold pack.

Other devices from Thermo Temp, Inc.

Questions

AI-generated answers, 24 Sep 2026

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

  • What is the primary purpose of the Hot/Ice Dual Function Equipment?

    This device is designed for thermal therapy applications. It functions as a water circulating pack that allows the user to select either hot or cold treatment based on their specific therapeutic needs.

  • How is this device regulated?

    The Hot/Ice Dual Function Equipment is regulated under the physical medicine specialty. It is classified as a water circulating hot or cold pack and is authorized under FDA 510(k) clearance K871962.

  • What is the regulatory classification of this thermal therapy device?

    This device is classified as a Class 2 medical device. It falls under the regulation number 890.5720, which pertains to water circulating hot or cold packs used in physical medicine.