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Advanced Medical Products Mini-M (TENS)

by Advanced Medical Products, Inc.

510(k) K852836

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 NumberK852836 Date28 Aug 1985ClearedStatusActive

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  • Withdrawn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, 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.

The Advanced Medical Products Mini-M (TENS) is a transcutaneous electrical nerve stimulation device designed for pain relief. It is classified as a Class 2 medical device under the FDA's regulatory framework.

The device is supplied sterile and intended for single-use applications. It is not MRI safe and should be stored in a cool, dry place. The product is authorized under FDA 510(k) clearance, with a decision date of 1985-08-28.

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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 Advanced Medical Products Mini-M TENS device used for?

    The Mini-M TENS is a transcutaneous electrical nerve stimulation device designed to provide pain relief.

  • Is the Mini-M TENS device sterile and intended for single use?

    Yes, the device is supplied sterile and is intended for single-use applications.

  • How should the Mini-M TENS device be stored?

    The device should be stored in a cool, dry place.

  • Is the Mini-M TENS device MRI safe?

    No, the Mini-M TENS device is not MRI safe.