510(k) Premarket Notification

Device Classification Name	Transcranial Magnetic Stimulator
510(k) Number	K143531
Device Name	Rapid Therapy System
Applicant	Magstim Company Limited Spring Gardens, Whitland Carmarthenshire,  GB SA34 OHR
Applicant Contact	Charles Hounsell
Correspondent	Hogan Lovells US LLP 1835 Market St., 29th Floor Philedelphia,  PA  19103
Correspondent Contact	Steven B Datlof
Regulation Number	882.5805
Classification Product Code	OBP
Date Received	12/12/2014
Decision Date	05/08/2015
Decision	Substantially Equivalent (SESE)
Regulation Medical Specialty	Neurology
510k Review Panel	Neurology
Summary	Summary
Type	Traditional
Reviewed by Third Party	No
Combination Product	No
Predetermined Change Control Plan Authorized	No
Recalls	CDRH Recalls