• 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, transcutaneous electrical, aesthetic purposes
510(k) Number K211055
Device Name Microcurrent device (Model: HBR2-1)
Shenzhen DJ Medical Equipment Co., Ltd.
Room 801, Building A, FirstFlag Science & Technology Park,
No. 26 Baili Road, Nanwan Street.
Shenzhen,  CN
Applicant Contact Jet Li
Guangzhou KEDA biology technology co ltd
6F, No.1 TianTai road, Science City, LuoGang District
Guangzhou,  CN
Correspondent Contact Jet Li
Regulation Number882.5890
Classification Product Code
Subsequent Product Code
Date Received04/09/2021
Decision Date 11/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No