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Magstim Rapid

by Magstim Corporation US

510(k) K992911

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 NumberK992911 Date7 Jan 2000ClearedStatusActive

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  • Withdrawn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 Magstim Rapid is an electrical stimulator device used for evoked response stimulation. It is designed for neurological applications and can be used for cortical and peripheral transcranial magnetic stimulation (TMS) research.

The device is supplied as a system with a 15-inch touchscreen and Windows-based software. It is FDA-cleared for the stimulation of peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain in patients 18 years or older, subject to territory registrations. The device is manufactured by Magstim Corporation US and has a device class of 2.

Other devices from Magstim Corporation US

  • Magstim 200-2

    Class II

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 Magstim Rapid used for?

    The Magstim Rapid is an electrical stimulator designed for neurological applications, including cortical and peripheral transcranial magnetic stimulation (TMS) research. It is FDA-cleared for stimulating peripheral nerves to relieve chronic intractable, post-traumatic, and post-surgical pain in patients 18 years or older.

  • How is the Magstim Rapid supplied?

    The device is supplied as a complete system with a 15-inch touchscreen and Windows-based software for operation and control. This integrated system allows for precise stimulation parameters and data collection during neurological research and clinical applications.

  • What is the regulatory status of the Magstim Rapid?

    The Magstim Rapid is FDA-cleared with a 510(k) number K992911 and has a device class of 2. It is manufactured by Magstim Corporation US and is subject to territory registrations for its approved indications. The device has been determined to be substantially equivalent to predicate devices.

  • Can the Magstim Rapid be reused or is it single-use?

    The device is designed for repeated use in clinical and research settings. As a Class 2 electrical stimulator system, it is intended for multiple applications rather than single-use. Proper maintenance and calibration according to the manufacturer's guidelines are required to ensure continued safe and effective operation.