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Model HS-2 Tens Device

by Technalithics Laboratories, Inc.

510(k) K962951

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 NumberK962951 Date6 Aug 1997ClearedStatusActive

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  • Withdrawn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
GZJ
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Model Hs-2 Tens Device is a transcutaneous nerve stimulator for pain relief. It is a device used to stimulate nerves for the relief of pain. The device is classified as a stimulator, nerve, transcutaneous, for pain relief, and is used in the medical specialty of neurology.

The device is supplied as a single unit and is intended for use in the symptomatic relief of chronic intractable pain. It is a class 2 device with the product code GZJ, and has been cleared by the FDA with the clearance number K962951. The device is available in one model, the Model Hs-2.

Questions

AI-generated answers, 27 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 Model HS-2 Tens Device used for?

    The Model HS-2 Tens Device is used for the symptomatic relief of chronic intractable pain by stimulating nerves.

  • Is the Model HS-2 Tens Device supplied as a single unit or in multiple parts?

    The Model HS-2 Tens Device is supplied as a single unit.

  • What is the regulatory status of the Model HS-2 Tens Device?

    The Model HS-2 Tens Device has been cleared by the FDA with the clearance number K962951.