MAGSTIM 200-2

K060847 · Magstim Company Us, LLC · GWF · Sep 26, 2006 · Neurology

Device Facts

• Record ID: K060847
• Device Name: MAGSTIM 200-2
• Applicant: Magstim Company Us, LLC
• Product Code: GWF · Neurology
• Decision Date: Sep 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

Stimulation of peripheral nerves for diagnostic purposes.

Device Story

Magstim Model 200-2 with Double 70mm Remote Coil is an evoked response electrical stimulator. Device delivers magnetic pulses to stimulate peripheral nerves for diagnostic purposes. Operated by clinicians in a diagnostic setting. Device generates magnetic fields via remote coil to induce electrical currents in nerve tissue; output used by clinicians to assess nerve function and conduction. Benefits include non-invasive diagnostic capability for neurological assessment.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Evoked response electrical stimulator; utilizes magnetic stimulation via Double 70mm Remote Coil. Class II device. Operates as a peripheral nerve stimulator.

Indications for Use

Indicated for stimulation of peripheral nerves for diagnostic purposes in patients requiring nerve conduction studies.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 26 2006

Dr. Reza Jalinous Magstim Company US, LLC 304 Cambridge Road, Suite 502 Woburn, Massachusetts 01801

Re: K060847

Trade/Device Name: Magstim Model 200-2 with Double 70mm Remote Coil Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: Class II Product Codes: GWF, JXE Dated: August 26, 2006 Received: August 28, 2006

Dear Dr. Jalinous:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if

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Page 2 – Dr. Reza Jalinous

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter wotification. The FDA finding of substantial equivalence of your device to a premainer results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Intribution of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

For N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

## 510(K) Number (if known):

Device Name: Magstim 2002

## Indications for Use:

Stimulation of peripheral nerves for diagnostic purposes.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off Division of General, «Res Jolari Editologi and Neurological Devic

11060847 510(k) Namber .

Prescription Use: (Per 21 CFR 801.109)

OR

Over-The-Counter Use: ________________________________________________________________________________________________________________________________________________________