FDA 510(k) Application Details - K010807

Device Classification Name Stimulator, Muscle, Powered

  More FDA Info for this Device
510(K) Number K010807
Device Name Stimulator, Muscle, Powered
Applicant HEALTH@FITNESS TECHNOLOGIES, INC.
KARAMANOVA 11
21000 SPLIT 21000 HR
Other 510(k) Applications for this Company
Contact IVAN VRDOLJAK
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 03/16/2001
Decision Date 08/09/2001
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



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