• 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 K213788
Device Name TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
Dongguan Bohuikang Technology Co.,Ltd
5th Floor,No 5, Second Street,Huaide Shui Xiang New Strict,
Humen Town
DongGuan,  CN 523165
Applicant Contact Rihua Meng
Guangdong Jianda Medical Technology Co., Ltd.
906 Room, Longxiang Garden, Tianhe District
Guangzhou,  CN 510000
Correspondent Contact Jett Lee
Regulation Number882.5890
Classification Product Code
Subsequent Product Codes
Date Received12/06/2021
Decision Date 05/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No