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Hot/Ice Disposable Blanket

by Thermo Temp, Inc. 2 variants

510(k) K833564

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 NumberK833564 Date28 Nov 1983ClearedStatusActive

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  • Withdrawn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, 6 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 Hot/Ice Disposable Blanket is a water-circulating pack designed for use in physical medicine applications. It functions as a thermal therapy device to provide hot or cold treatment to a patient.

This device is supplied as a single-use product. It is regulated under FDA 510(k) clearance K833564.

Other devices from Thermo Temp, Inc.

Questions

AI-generated answers, 6 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 Hot/Ice Disposable Blanket used for?

    The Hot/Ice Disposable Blanket is a water-circulating pack designed for physical medicine applications. It serves as a thermal therapy device to deliver either hot or cold treatment to a patient.

  • Is the Hot/Ice Disposable Blanket reusable?

    This device is manufactured as a single-use product. It is intended to be used once and then disposed of, rather than being cleaned or reprocessed for multiple patients.

  • What is the regulatory status of this device?

    The device is regulated under FDA 510(k) clearance number K833564. This indicates the product has been reviewed and cleared for market entry through the traditional 510(k) regulatory pathway.