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Alpha-Stim CS

by Electromedical Products, Inc. 2 variants

510(k) K903014

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK903014 Date12 May 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
QJQ
Device Class
Class II
Regulation
21 CFR Part 882.5800
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 Alpha-Stim CS is a cranial electrotherapy stimulator to treat insomnia and/or anxiety. It is classified as a Class II medical device under regulation number 882.5800.

The device received FDA 510(k) clearance (K903014) on May 12, 1992, and is manufactured by Electromedical Products, Inc. It is intended for use in neurology-related applications as indicated by its product code QJQ and advisory committee classification.

Other devices from Electromedical Products, Inc.

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 Alpha-Stim CS used for?

    The Alpha-Stim CS is a cranial electrotherapy stimulator intended to treat insomnia and/or anxiety. It is designed for neurology-related applications as indicated by its product code QJQ and advisory committee classification in neurology.

  • How was the Alpha-Stim CS authorized for market release?

    The Alpha-Stim CS received FDA 510(k) clearance under submission K903014 on May 12, 1992, based on a determination of substantial equivalence to a predicate device. This clearance allows it to be marketed for its intended use.

  • Who manufactures the Alpha-Stim CS and where is it made?

    The Alpha-Stim CS is manufactured by Electromedical Products, Inc., located at 12591 Crenshaw Blvd., Hawthorne, CA 90250, United States. The manufacturer’s FEI numbers are listed in the openfda field.

  • What regulatory classification does the Alpha-Stim CS have?

    The Alpha-Stim CS is classified as a Class II medical device under FDA regulation number 882.5800, which covers cranial electrotherapy stimulators for treating insomnia and/or anxiety.