FDA 510(k) Application Details - K060368

Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief

  More FDA Info for this Device
510(K) Number K060368
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant INSPIRSTAR, INC.
891 N. NAPLES DR.
CHANDLER, AZ 85226 US
Other 510(k) Applications for this Company
Contact NING WU
Other 510(k) Applications for this Contact
Regulation Number 882.5890

  More FDA Info for this Regulation Number
Classification Product Code GZJ
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 02/13/2006
Decision Date 03/14/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact