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High Speed Magnetic Stimulator

by Cadwell Laboratories, Inc.

510(k) K905059

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 NumberK905059 Date18 Sep 1991ClearedStatusActive

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  • Withdrawn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, 23 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 High Speed Magnetic Stimulator is an electrical evoked‑response stimulator classified as a Class II device. It is intended for use in neurological applications to deliver rapid magnetic stimulation for diagnostic or monitoring purposes.

The device received traditional FDA 510(k) clearance (K905059) as substantially equivalent to a predicate device, with a product code GWF. It is listed as a Class II stimulator, reviewed by the Neurology advisory committee, and is identified as a Cadwell Laboratories, Inc. product.

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