• 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 K200177
Device Name Low-frequency Multi-function physiotherapy instrument
Shenzhen Kentro Medical Electronics Co., Ltd
No.3, Xihu industry zone, Xikeng Village, Henggang Town
Longgang District,Shenzhen City,  CN 518115
Applicant Contact Zewu Zhang
Guangzhou GLOMED Biological Technology Co., Ltd.
Room 2231, Building 1, Ruifeng center, Kaichuang road,
Huangpu district
Guangzhou,  CN 51006
Correspondent Contact Cassie Lee
Regulation Number882.5890
Classification Product Code
Subsequent Product Code
Date Received01/24/2020
Decision Date 03/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No