FDA 510(k) Application Details - K062631

Device Classification Name	More FDA Info for this Device
510(K) Number	K062631
Device Name	MYOMO E100
Applicant	MYOMO, INC. 529 MAIN STREET SUITE 205 BOSTON, MA 02129 US Other 510(k) Applications for this Company
Contact	KATE ZEBROSE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OAL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/2006
Decision Date	04/12/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review