FDA 510(k) Application Details - K070176

Device Classification Name Wheelchair, Mechanical

  More FDA Info for this Device
510(K) Number K070176
Device Name Wheelchair, Mechanical
Applicant MAXHEALTH CORP.
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY, TW
Other 510(k) Applications for this Company
Contact JEN KE-MIN
Other 510(k) Applications for this Contact
Regulation Number 890.3850

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

  More FDA Info for this Product Code
Date Received 01/18/2007
Decision Date 03/01/2007
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



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