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Alpha-Stim 350

by Electromedical Products, Inc. 2 variants

510(k) K881753

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 NumberK881753 Date30 Aug 1988ClearedStatusActive

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  • Withdrawn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, 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 Alpha-Stim 350 is a cranial electrotherapy stimulation device used for neuromodulation therapy. It is designed to treat mental health disorders and pain conditions through non-invasive brain stimulation and microcurrent therapy.

The device is supplied by Electromedical Products, Inc. and has FDA 510K clearance with the product code GZJ. It is intended for clinical use and research applications, with specific regulatory authorization documented under K881753.

Other devices from Electromedical Products, Inc.

  • Alpha-Stim CS

    Class II

  • Alpha-Stim 2000

    Class II

  • Alpha-Stim 350

    Class II

  • Alpha-Stim Cs

    Class II

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 Alpha-Stim 350 device used for?

    The Alpha-Stim 350 is a cranial electrotherapy stimulation device designed for neuromodulation therapy to treat mental health disorders and pain conditions through non-invasive brain stimulation and microcurrent therapy.

  • How is the Alpha-Stim 350 supplied and what is its regulatory status?

    The Alpha-Stim 350 is supplied by Electromedical Products, Inc. and has FDA 510K clearance with product code GZJ, documented under K881753 for clinical use and research applications.

  • Is the Alpha-Stim 350 a single-use or reusable device?

    The device information does not specify whether the Alpha-Stim 350 is single-use or reusable, as this detail is not provided in the device data.

  • What are the storage requirements for the Alpha-Stim 350?

    Storage requirements for the Alpha-Stim 350 are not specified in the provided device data, so specific storage conditions cannot be determined from this information.