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 K221384
Device Name Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
Applicant
Hivox Biotek Inc.
5F., No. 123, Xingde Rd., Sanchong Dist.
New Taipei City,  TW 24158
Applicant Contact Aaron Huang
Correspondent
Hivox Biotek Inc.
5F., No. 123, Xingde Rd., Sanchong Dist.
New Taipei City,  TW 24158
Correspondent Contact Aaron Huang
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
IRT   NGX  
Date Received05/13/2022
Decision Date 06/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
-
-