Magstim Rapid

FDA 510(k) K992911 · Magstim Corporation US

Substantially Equivalent

510(k) numberK992911

Submission

Device name
Magstim Rapid
Applicant
Magstim Corporation US
New York, NY, US
Received
August 30, 1999
Decision date
January 7, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GWF – Stimulator, Electrical, Evoked Response
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1870
Specialty
Neurology

Other 510(k)s with product code GWF

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K253301BraiN20® (BraiN20)GWF · Traditional Time IS Brain, S.L.06/27/2026SE
K252842SafeOp 3: Neural Informatix SystemGWF · Traditional Alphatec Spine, Inc.01/11/2026SE
K243982Nicolet EDXGWF · Special Natus Neurology Incorporated01/22/2025SE
K243495Natus Ultrapro S100 (982A0594)GWF · Special Natus Neurology Incorporated12/12/2024SE
K242345Delphi StimulatorGWF · Traditional Quantalx Neuroscience11/05/2024SE
K234092SafeOp 3: Neural Informatix SysteemGWF · Traditional Alphatec Spine, Inc.04/19/2024SE
K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)GWF · Traditional Soterix Medical, Inc.03/25/2024SE
K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Special Inomed Medizintechnik GmbH10/27/2023SE
K230415Cadwell GuardianGWF · Traditional Cadwell Industries, Inc.08/17/2023SE
K213849SafeOp 2: Neural Informatix SystemGWF · Traditional Alphatec Spine, Inc.03/09/2022SE

Questions and answers

When was Magstim Rapid cleared by the FDA?

Magstim Rapid (K992911) received a 510(k) decision of Substantially Equivalent on January 7, 2000, 130 days after the submission was received.

What is the product code of K992911?

The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.