FDA 510(k) Application Details - K152827

Device Classification Name Wheelchair, Mechanical

  More FDA Info for this Device
510(K) Number K152827
Device Name Wheelchair, Mechanical
Applicant Rupiani
74 Avenue Du 8 Mai 1945
Vaudex En Velin 69120 FR
Other 510(k) Applications for this Company
Contact Jean-Marie Mangenot
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 09/29/2015
Decision Date 02/19/2016
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