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BodyHeat Thermal Regulating System

by Medadvances, Inc.

510(k) K902650

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 NumberK902650 Date20 Dec 1990ClearedStatusActive

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  • Withdrawn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
Bodyheat
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, 1 Oct 2026

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

The BodyHeat Thermal Regulating System is a Class II medical device designed for maintaining patient body temperature during surgical procedures. According to the FDA’s device classification, it functions as a thermal regulating system, ensuring precise temperature control to prevent hypothermia or hyperthermia in patients.

This system is intended for use in operating rooms and is supplied as a reusable device. It has received FDA 510(k) clearance under the traditional pathway, with a decision date of December 20, 1990. The device is regulated under FDA regulation number 870.5900 and is categorized under the product code DWJ. No third-party review was involved in its clearance process.

Other devices from Medadvances, Inc.

  • Biotemp

    Class II

  • Heatwave

    Class II

Questions

AI-generated answers, 1 Oct 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 BodyHeat Thermal Regulating System used for?

    The BodyHeat Thermal Regulating System is designed to maintain patient body temperature during surgical procedures in operating rooms. It helps prevent complications from hypothermia or hyperthermia by providing precise thermal regulation, ensuring patient safety and stability throughout surgery.

  • Is the BodyHeat Thermal Regulating System reusable or single-use?

    The BodyHeat Thermal Regulating System is supplied as a reusable device. This design allows for cost-effective use across multiple surgical procedures while maintaining consistent performance and reliability.

  • What regulatory approval does the BodyHeat Thermal Regulating System hold?

    The BodyHeat Thermal Regulating System has received FDA 510(k) clearance under the traditional pathway, demonstrating substantial equivalence to a predicate device. It is classified as a Class II medical device and regulated under FDA regulation number 870.5900.

  • How is the BodyHeat Thermal Regulating System categorized by the FDA?

    The BodyHeat Thermal Regulating System is categorized under the product code DWJ by the FDA. This classification aligns with its function as a thermal regulating system, ensuring it meets the regulatory requirements for its intended use in operating rooms.

  • What are the key specifications or features of the BodyHeat Thermal Regulating System?

    The BodyHeat Thermal Regulating System is intended for use in operating rooms and is designed to provide precise temperature control. While specific technical details like temperature ranges or control mechanisms are not provided in the data, its FDA clearance and classification as a reusable Class II device indicate it is engineered for reliability and safety in surgical settings.