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 K260425
Device Name TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
Applicant
Hivox Biotek, Inc.
5f., # 123, Xingde Rd., Sanchong District
New Taipei City,  TW 24158
Applicant Contact Adam Huang
Correspondent
Hivox Biotek, Inc.
5f., # 123, Xingde Rd., Sanchong District
New Taipei City,  TW 24158
Correspondent Contact Adam Huang
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
IRT   NGX  
Date Received02/10/2026
Decision Date 06/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-