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Transcranial Electrotherapy Stimulator-A, Model TESA-1

by Kalaco Scientific, Inc.

510(k) K024377

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 NumberK024377 Date21 Jul 2003ClearedStatusActive

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  • Withdrawn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, 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 Transcranial Electrotherapy Stimulator-A, Model Tesa-1 is a cranial electrotherapy stimulator. It is designed to treat insomnia and anxiety.

This device is regulated under FDA 510(k) clearance, identified by K-number K024377. It is classified as a Class 2 medical device under regulation number 882.5800.

Questions

AI-generated answers, 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.

  • What is the primary purpose of the Tesa-1 stimulator?

    The Transcranial Electrotherapy Stimulator-A, Model Tesa-1 is a cranial electrotherapy stimulator specifically designed to treat patients suffering from insomnia and anxiety.

  • What is the regulatory status of this device?

    The Tesa-1 is regulated under FDA 510(k) clearance, identified by K-number K024377. It is classified as a Class 2 medical device under regulation number 882.5800.

  • Which medical specialty oversees this device?

    The device is categorized under the neurology medical specialty, as indicated by the advisory committee description associated with its regulatory filing.