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Medaid Dual Channel Tens

by Par Medex, Ltd.

510(k) K834334

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 NumberK834334 Date13 Feb 1984ClearedStatusActive

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  • Withdrawn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
FDA applicant
Par Medex , Ltd.
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 MEDAID DUAL CHANNEL TENS is a transcutaneous electrical nerve stimulation device designed for pain relief. It is a dual-channel TENS unit that delivers electrical pulses through electrodes to stimulate nerves and modulate pain signals.

This device is supplied as a reusable electronic pulse massager and is FDA 510(k) cleared under K834334 with product code GZJ. It is intended for use in clinical or home settings for pain management, and its authorization is based on substantial equivalence to a legally marketed device.