• 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 K183215
Device Name Focus TENS Therapy, Model PM710-M/-L
Omron Healthcare, Inc.
1925 West Field Court, Suite 100
Lake Forest,  IL  60045
Applicant Contact Renee Thornborough
Experien Group
224 Airport Parkway, Suite 250
San Jose,  CA  95110
Correspondent Contact Ronald S. Warren
Regulation Number882.5890
Classification Product Code
Date Received11/19/2018
Decision Date 09/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No