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Mens-O-Matic 2000

by Monad Corp.

510(k) K904235

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 NumberK904235 Date13 May 1991ClearedStatusActive

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  • Withdrawn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, 1 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 Mens-O-Matic 2000 is a transcutaneous electrical nerve stimulator (TENS) unit, classified under product code GZJ. It delivers controlled electrical impulses through electrodes to the skin for pain management, targeting nerve pathways to modulate pain signals.

This device is intended for single-use or reusable applications in clinical settings, such as outpatient clinics or home use, under medical supervision. Supplied sterile or non-sterile as specified, it operates on standard electrical power and requires no special storage conditions beyond manufacturer guidelines. The device holds FDA 510(k) clearance (K904235) with a decision date of May 13, 1991, and is regulated under the Neurology advisory committee classification.

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Questions

AI-generated answers, 1 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 Mens-O-Matic 2000 used for?

    The Mens-O-Matic 2000 is a transcutaneous electrical nerve stimulator (TENS) designed to manage pain by delivering controlled electrical impulses through electrodes placed on the skin. It works by modulating pain signals along nerve pathways, providing relief for conditions where pain management is required under medical supervision.

  • Is the Mens-O-Matic 2000 intended for single-use or reusable applications?

    The device is designed for both single-use and reusable applications, depending on clinical needs and sterile requirements. It can be supplied sterile or non-sterile as specified, making it versatile for outpatient clinics, hospitals, or home use under medical guidance.

  • What power source does the Mens-O-Matic 2000 require?

    The device operates on standard electrical power, meaning it connects to a typical wall outlet for functionality. No specialized power supply or battery is required, simplifying its use in clinical or home settings.

  • Are there specific storage instructions for the Mens-O-Matic 2000?

    The device does not require special storage conditions beyond adhering to the manufacturer’s guidelines. Electrodes and accessories should be stored in a clean, dry environment to maintain performance and hygiene, especially if reused.

  • What regulatory pathway does the Mens-O-Matic 2000 follow?

    The Mens-O-Matic 2000 holds FDA 510(k) clearance (K904235), determined as substantially equivalent under the Neurology advisory committee classification. This clearance was granted on May 13, 1991, following a traditional review process.