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, muscle, powered, for muscle conditioning
510(k) Number K201845
Device Name Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
Applicant
Guangzhou Longest Science & Technology Co., LTD.
5 & 6f, Building B4, No. 11, Kaiyuan Avenue, Science City
Guangzhou,  CN 510530
Applicant Contact Xiaobing Luo
Correspondent
Guangzhou KEDA Biological Tech Co., LTD.
6F, No. 1 TianTai Road, Science City, LuoGang District
Guangzhou,  CN
Correspondent Contact Jet Li
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Codes
NUH   NYN  
Date Received07/06/2020
Decision Date 10/08/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-