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In the USA federal law regulates the sale of Medical Devices through the US Food and Drug Administration (FDA). This is done to ensure safety and effectiveness. Devices which are permitted to be marketed for their intended use must either have a 510(k) or PMA clearance.

The Magstim 2002, Standard Rapid2, Super Rapid2, Double 70mm Remote Control Coil, Double 90mm Remote Control Coil, Air Film Coil, Air Cooled Coil, and D702 Coil are all FDA 510(k) cleared (K060847, K051864, K080499, K130403).

K060847, K051864, K080499, K130403: The intended use is peripheral nerve stimulation.

The Magstim Rapid2 Therapy System has 510(k) clearance (K143531) and is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

The use of devices for other than their FDA cleared intended use is considered as investigational. Such use is only permitted if the Investigational Device Exemption (IDE) guidelines have been followed. For full information on this, please consult the FDA's website (www.fda.gov).

All investigational devices must be labeled in accordance with the labeling provisions of the IDE regulations (§812.5) and must bear the statement "CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use."

Please note that transcranial magnetic stimulation (TMS, rTMS) with Magstim stimulators is considered investigational in the USA except for the above cleared intended use.

Items marked with are investigational devices and for research use only. CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use.

About Jali Medical

Established in 1991, Jali Medical is a company at the cutting edge of the emerging field of non-invasive brain stimulation. We are proud to be the US distributor for the best magnetic and electrical nerve stimulation equipment and accessories available.

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Jali Medical, Inc.
330 Bear Hill Road, Suite 303
Waltham, MA 02451
Phone(781) 376 0008 | (888) 959 JALI
Fax(781) 376 0808
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