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Wave Gate

by Wolfline Corp.

510(k) K853412

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 NumberK853412 Date28 Oct 1985ClearedStatusActive

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  • Withdrawn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
GWE
Device Class
Class II
Regulation
21 CFR Part 882.1890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Wave Gate is a Photic, Evoked Response Stimulator, classified as a device with a device class of 2. It is used in the field of Neurology.

The Wave Gate is supplied with an FDA 510(k) authorization, specifically with the clearance type Traditional and the decision description Substantially Equivalent. The device has a product code of GWE and a regulation number of 882.1890.

Questions

AI-generated answers, 25 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 Wave Gate used for?

    The Wave Gate is used in the field of Neurology as a Photic Evoked Response Stimulator.

  • What kind of authorization does the Wave Gate have?

    The Wave Gate has an FDA 510(k) authorization with a clearance type of Traditional and a decision description of Substantially Equivalent.

  • What is the product code of the Wave Gate?

    The product code of the Wave Gate is GWE.

  • What is the device class of the Wave Gate?

    The Wave Gate is classified as a device with a device class of 2.