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Xltek Evoked Potential Headbox, Model EP-4-RP

by Excel Tech., Ltd.

510(k) K010090

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 NumberK010090 Date26 Mar 2001ClearedStatusActive

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  • Withdrawn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)

Full name
Xltek Evoked Potential Headbox, Model Ep-4-Rp (Proposed)
510(k) Number
FDA Product Code
GWF
FDA applicant
Excel Tech. , Ltd.
Device Class
Class II
Regulation
21 CFR Part 882.1870
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 XLTEK Evoked Potential Headbox, model EP-4-RP, is an evoked response electrical stimulator. It is designed to apply an electrical stimulus to a patient via skin electrodes to facilitate the measurement of an evoked response.

This device is classified as a Class II medical device under the neurology specialty. It has received FDA 510(k) clearance for use as an electrical stimulator for evoked response measurements.

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