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 K232675
Device Name Heating Tens, FT-615
Applicant
Hivox Biotek Inc.
5F., No. 123, Xingde Rd., Sanchong Dist.
New Taipei City,  TW 24158
Applicant Contact Leslie Peng
Correspondent
Hivox Biotek Inc.
5F., No. 123, Xingde Rd., Sanchong Dist.
New Taipei City,  TW 24158
Correspondent Contact Leslie Peng
Regulation Number882.5890
Classification Product Code
NUH  
Date Received09/01/2023
Decision Date 10/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-