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 K213835
Device Name TENS & EMS Device
Applicant
Shenzhen Jian Feng Electronic Technology Co., Ltd.
#902, 903 Jialingyu Industrial Bldg., Dapu Rd.,
Houting Village, Shajing Town, Baoan District
Shenzhen,  CN 518104
Applicant Contact Feng Wen
Correspondent
Shenzhen Jian Feng Electronic Technology Co., Ltd.
#902, 903 Jialingyu Industrial Bldg., Dapu Rd.,
Houting Village, Shajing Town, Baoan District
Shenzhen,  CN 518104
Correspondent Contact Feng Wen
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received12/09/2021
Decision Date 03/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-