• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name stimulator, transcutaneous electrical, aesthetic purposes
510(k) Number K161484
Device Name ZIIP Device
1871 Trestle Glen Rd.,
Piedmont,  CA  94610
Applicant Contact David Mason
1871 Trestle Glen Rd.,
Piedmont,  CA  94610
Correspondent Contact David Mason
Regulation Number882.5890
Classification Product Code
Date Received05/31/2016
Decision Date 02/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No