FDA 510(k) Application Details - K130424

Device Classification Name Stimulator, Muscle, Powered

  More FDA Info for this Device
510(K) Number K130424
Device Name Stimulator, Muscle, Powered
Applicant STIMEL LTD
57 LAZY BROOK ROAD
MONROE, CT 06468 US
Other 510(k) Applications for this Company
Contact RAYMOND J KELLY IV
Other 510(k) Applications for this Contact
Regulation Number 890.5850

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

  More FDA Info for this Product Code
Date Received 02/20/2013
Decision Date 07/11/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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