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 K230164
Device Name TENS and EMS Stimulation (OTC)
Applicant
Changsha Yuwen Medical Equipment Co., Ltd.
Rm. 2404, Kairui Bldg., # 245 Laodong W. Rd.
Tianxin District
Changsha,  CN 430103
Applicant Contact Chen Dahui
Correspondent
Changsha Yuwen Medical Equipment Co., Ltd.
Rm. 2404, Kairui Bldg., # 245 Laodong W. Rd.
Tianxin District
Changsha,  CN 430103
Correspondent Contact Chen Dahui
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received01/20/2023
Decision Date 04/10/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-