Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 K161453
Device Name WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
Applicant
Well-Life Healthcare Limited
1f, #16, Lane 454, Jungjeng Rd.
Yunghe Dist, New Taipei City,  TW 234
Applicant Contact CHIN-CHIH HSIEH
Correspondent
Well-Life Healthcare Limited
1f, #16, Lane 454, Jungjeng Rd.
Yunghe Dist, New Taipei City,  TW 234
Correspondent Contact CHIN-CHIH HSIEH
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
NGX   NYN  
Date Received05/26/2016
Decision Date 12/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-