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ST10 Progr. Evoked Response Stimulator

by Teca, Inc.

510(k) K822744

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 NumberK822744 Date3 Nov 1982ClearedStatusActive

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  • Withdrawn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
GWF
Device Class
Class II
Regulation
21 CFR Part 882.1870
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 ST10 Progr. Evoked Response Stimulator is an electrical stimulator device designed to apply an electrical stimulus to a patient via skin electrodes. It is used for the purpose of measuring the evoked response.

This device is manufactured by Teca, Inc. and received FDA 510(k) clearance under K822744.

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Questions

AI-generated answers, 22 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 ST10 Progr. Evoked Response Stimulator?

    This device is designed to apply an electrical stimulus to a patient through the use of skin electrodes. It is specifically intended for the measurement of evoked responses.

  • Who is the manufacturer of this stimulator?

    The ST10 Progr. Evoked Response Stimulator is manufactured by Teca, Inc.

  • What is the regulatory status of this device?

    The device received FDA 510(k) clearance under K822744. It was processed through a traditional submission route and classified under the neurology advisory committee.