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 K251429
Device Name OTC 4-Channel Rechargeable TENS Unit
Applicant
Changsha Anxiang Medical Technology Co., Ltd.
9th Floor, R&D Center And Supporting Projects 101
# 18 Shaoshan Middle Rd., Dongtang St. Yuhua District
Changsha,  CN 410000
Applicant Contact William Fu
Correspondent
Changsha Anxiang Medical Technology Co., Ltd.
9th Floor, R&D Center And Supporting Projects 101
# 18 Shaoshan Middle Rd., Dongtang St. Yuhua District
Changsha,  CN 410000
Correspondent Contact William Fu
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received05/08/2025
Decision Date 08/28/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-