FDA 510(k) Application Details - K192607

Device Classification Name Massager, Powered Inflatable Tube

  More FDA Info for this Device
510(K) Number K192607
Device Name Massager, Powered Inflatable Tube
Applicant Viasonix Ltd.
10 Hamelacha Street
Raananna 4366105 IL
Other 510(k) Applications for this Company
Contact Shlomi Deler
Other 510(k) Applications for this Contact
Regulation Number 890.5650

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

  More FDA Info for this Product Code
Date Received 09/20/2019
Decision Date 12/19/2019
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