• 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 K192087
Device Name Combo Electrotherapy Device
Shenzhen Roundwhale Technology Co., Ltd.
202, 2/F, Building 27, Dafa Industrial Park
Longxi Community, Longgang Street
Shenzhen,  CN 518108
Applicant Contact Kevin Zhang
Shenzhen Reanny Medical Devices Management Consulting Co Ltd
Room 2012#, Gebu commercial building, Hongxing community,
Songgang street
Shenzhen,  CN 518105
Correspondent Contact Reanny Wang
Regulation Number882.5890
Classification Product Code
Subsequent Product Codes
Date Received08/05/2019
Decision Date 11/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No