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 K223151
Device Name Nu-beca Transcutaneous Electrical Nerve Stimulation
Applicant
Nu-Beca & Maxcellent Co.
3F-1, No. 45, Dexing W. Rd
Taipei,  TW 111046
Applicant Contact David Tsai
Correspondent
TaiDoc Technology COrporation
B1-7F, No.127, Wugong 2nd Rd.
New Taipei City,  TW 24888
Correspondent Contact Diana Sung
Regulation Number882.5890
Classification Product Code
NUH  
Date Received10/05/2022
Decision Date 07/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-