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Thermorite Model HC-83 Hypo/Hyperthermia Unit

by Thermorite, Inc.

510(k) K854856

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 NumberK854856 Date2 Jun 1986ClearedStatusActive

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  • Withdrawn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
DWJ
Device Class
Class II
Regulation
21 CFR Part 870.5900
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Thermorite Model HC-83 Hypo/Hyperthermia Unit is a thermal regulating system designed to provide both hypothermia and hyperthermia treatments. This device is classified as a System, Thermal Regulating and is intended for medical applications requiring controlled temperature management.

The unit is supplied by Thermorite, Inc. and has FDA 510(k) clearance with the product code DWJ. It is a reusable device that falls under device class 2. The device is authorized for use in cardiovascular applications and was cleared by the FDA on June 2, 1986.

Questions

AI-generated answers, 26 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 Thermorite Model HC-83 used for?

    The Thermorite Model HC-83 is used for controlled temperature management in medical applications, specifically for hypothermia and hyperthermia treatments, including cardiovascular applications.

  • Is the Thermorite Model HC-83 a single-use or reusable device?

    The Thermorite Model HC-83 is a reusable device, classified as a System, Thermal Regulating, and falls under device class 2.

  • What is the regulatory status of the Thermorite Model HC-83?

    The Thermorite Model HC-83 has FDA 510(k) clearance, with the product code DWJ, and was cleared by the FDA on June 2, 1986.

  • What type of applications is the Thermorite Model HC-83 authorized for?

    The Thermorite Model HC-83 is authorized for use in cardiovascular applications.