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Totally Cool TC-1

by Electro Science Technologies, Inc.

510(k) K943844

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)SN Traditional NumberK943844 Date9 Feb 1995DecidedStatusActive

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  • Withdrawn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)

Full name
Totally Cool(Tm) Tc-1
510(k) Number
FDA Product Code
ILO
Device Class
Class II
Regulation
21 CFR Part 890.5720
Advisory Committee
Physical Medicine
FDA Decision
SN

Overview

AI-generated summary, 19 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 Totally Cool TC-1 is a Pack, Hot or Cold, Water Circulating, designed to deliver controlled thermal therapy via circulating water. It provides adjustable temperature settings for therapeutic applications in physical medicine, facilitating either heating or cooling treatments for targeted tissue areas.

This device is intended for single-use or reusable applications, depending on manufacturer guidelines, and is classified as a Class II medical device under FDA regulations (890.5720). Supplied as a sterile or non-sterile pack, it requires proper storage and handling to maintain performance. The device holds an FDA 510(k) clearance (K943844) for traditional review in the Physical Medicine category, with no third-party involvement.

Other devices from Electro Science Technologies, Inc.

Questions

AI-generated answers, 19 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 types of thermal treatments can the Totally Cool TC-1 provide, and how is the temperature controlled?

    The Totally Cool TC-1 delivers both heating and cooling treatments through circulating water, making it versatile for physical medicine applications. It features adjustable temperature settings to precisely control the thermal therapy delivered to targeted tissue areas, allowing clinicians to tailor the treatment to patient needs.

  • Is the Totally Cool TC-1 intended for single-use or reusable applications, and how should it be handled?

    The device is designed for either single-use or reusable applications, depending on the manufacturer’s guidelines. Proper storage and handling are essential to maintain performance, particularly if reused, as this ensures hygiene and functionality for subsequent treatments.

  • What regulatory pathway does the Totally Cool TC-1 follow, and what does this mean for its use in clinical settings?

    The Totally Cool TC-1 holds an FDA 510(k) clearance (K943844) under traditional review in the Physical Medicine category. This means it has been deemed substantially equivalent to a legally marketed device for some indications, allowing its use in clinical settings for controlled thermal therapy as described in its labeling.

  • Are the Totally Cool TC-1 packs supplied sterile, and how should they be stored?

    The device is supplied as either a sterile or non-sterile pack, depending on the specific configuration. Sterility is critical for maintaining safety, so storage must follow manufacturer instructions to preserve integrity—typically in a clean, dry environment away from direct sunlight or extreme temperatures.