• 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, nerve, transcutaneous, over-the-counter
510(k) Number K171599
Device Name WiTouch Pro, WiTouch, Neubac
Hollywog LLC
2830 Amnicola Highway
chattanooga,  TN  37406
Applicant Contact michael treas
Hollywog LLC
2830 Amnicola Highway
chattanooga,  TN  37406
Correspondent Contact michael treas
Regulation Number882.5890
Classification Product Code
Subsequent Product Code
Date Received06/01/2017
Decision Date 09/22/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No