• 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 K190115
Device Name MHD TENS
MingHuangDa Electronic Co., Ltd
Floor6, Building A, Taixinglong Industrial Park
Hezhou Village, Xixiang Town
Baoan District, Shenzhen,  CN 518100
Applicant Contact Zhang Guixiang
Shanghai CV Technology Co., Ltd.
Room 903, No.19 Dongbao Road
Songjiang Area
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number882.5890
Classification Product Code
Subsequent Product Code
Date Received01/24/2019
Decision Date 06/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No