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T-Pad

by Gaymar Industries, Inc.

510(k) K760527

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 NumberK760527 Date3 Sep 1976ClearedStatusActive

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  • Withdrawn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, 28 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 T-Pad is a Hot Or Cold, Water Circulating Pack, classified as a Class 2 Physical Medicine device with product code ILO. It is designed to provide temperature management. The device is substantially equivalent to other devices on the market.

The T-Pad is supplied by Gaymar Industries, Inc. and has been cleared through the Traditional 510(k) pathway with FDA 510(k) clearance number K760527. The device is regulated under regulation number 890.5720 and has a registration number. It is intended for use in physical medicine.

Other devices from Gaymar Industries, Inc.

See all devices from Gaymar Industries, Inc. →

Questions

AI-generated answers, 28 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 T-Pad used for?

    The T-Pad is used for temperature management in physical medicine.

  • How is the T-Pad supplied?

    The T-Pad is supplied by Gaymar Industries, Inc.

  • What is the regulatory status of the T-Pad?

    The T-Pad has been cleared through the Traditional 510(k) pathway with FDA 510(k) clearance number K760527.

  • What type of device is the T-Pad?

    The T-Pad is classified as a Class 2 Physical Medicine device with product code ILO.