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
510(k) Number K181688
Device Name R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator
Applicant
Shenzhen Roundwhale Technology Co. , Ltd.
# 615, Bldg. C Of Sanlian Industrial Zone, Shiyan
Baoan District
Shenzhen,  CN 518108
Applicant Contact Kevin Zhang
Correspondent
Shenzhen Roundwhale Technology Co. , Ltd.
# 615, Bldg. C Of Sanlian Industrial Zone, Shiyan
Baoan District
Shenzhen,  CN 518108
Correspondent Contact Kevin Zhang
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
GZJ  
Date Received06/26/2018
Decision Date 09/07/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-