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 K182767
Device Name V2 OTC Pain Relief TENS
Applicant
Everyway Medical Instruments Co., Ltd.
3Fl., No. 5, Lane 155, Sec. 3 Beishen Rd.
Shenkeng Dist.
New Taipei City,  TW 22203
Applicant Contact Paul Hung
Correspondent
DuVal & Associates
825 Nicollet Mall, Suite 1820
Minneapolis,  MN  55402
Correspondent Contact Aaron Hage
Regulation Number882.5890
Classification Product Code
NUH  
Date Received09/28/2018
Decision Date 10/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
-
-