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Therasage Heating Pad

by Therasage Corporation

510(k) K120254

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 NumberK120254 Date6 Mar 2012ClearedStatusActive

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  • Withdrawn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
ILY
Device Class
Class II
Regulation
21 CFR Part 890.5500
Advisory Committee
Physical Medicine
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.

A heating pad is a device designed to provide localized heat therapy for pain relief and muscle relaxation. This device is intended to deliver deep-penetrating heat to support circulation and recovery.

The Therasage Heating Pad is supplied as a reusable device for use in home or clinical settings. It features adjustable temperature settings and auto shut-off for safe operation, and is authorized under FDA 510(k) clearance K120254 with product code ILY.

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 Therasage Heating Pad used for?

    The Therasage Heating Pad is designed to provide localized heat therapy for pain relief and muscle relaxation by delivering deep-penetrating heat to support circulation and recovery.

  • Is the Therasage Heating Pad reusable or single-use?

    The Therasage Heating Pad is supplied as a reusable device, meaning it can be used multiple times in home or clinical settings after proper cleaning and maintenance.

  • What safety features does the Therasage Heating Pad include?

    The device features adjustable temperature settings and an auto shut-off function to ensure safe operation during use, helping prevent overheating and promote user safety.

  • How is the Therasage Heating Pad supplied and where can it be used?

    The Therasage Heating Pad is supplied as a reusable unit intended for use in both home and clinical environments, offering flexibility for personal or professional heat therapy applications.