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Wireless Ambulatory EEG, Model EX-AMB-WIRELESS

by Excel Tech., Ltd. 510(k)

Active United States

510(k) K001103

Overview

The Wireless Ambulatory EEG, Model EX-AMB-WIRELESS is a Full-Montage Standard Electroencephalograph (product code GWQ), designed for continuous, wireless recording of brain electrical activity outside a clinical setting. It captures EEG signals from multiple electrodes placed on the scalp, enabling long-term monitoring of neurological activity in ambulatory patients.

This device is intended for single-use and operates without wired connections, transmitting data wirelessly for real-time or delayed analysis. It is classified as Class II under FDA regulations (21 CFR 882.1400) and has received FDA 510(k) clearance (K001103) as substantially equivalent to predicate devices. No specific MRI safety or sterility requirements are noted in the regulatory submission.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001103 Date30 Jun 2000ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Wireless Ambulatory EEG, Model Ex-Amb-Wireless (Proposed)
510(k) Number
FDA Product Code
GWQ
FDA applicant
Excel Tech. , Ltd.
Device Class
Class II
Regulation
21 CFR Part 882.1400
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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