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, nerve, battery-powered
510(k) Number K121743
Device Name EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
Applicant
SUNMED LLC
C/O EASYMED INSTRUMENTS CO,5/ -6/F,BLOCK A,GUPO GONGMAO BLDG
FENGXIN RD, FENGXIANG INDUSTRIAL DISTRICT
DALIANG, SHUNDE, FOSHAN,  CN 528300
Applicant Contact WU TINGJIE
Correspondent
SUNMED LLC
C/O EASYMED INSTRUMENTS CO,5/ -6/F,BLOCK A,GUPO GONGMAO BLDG
FENGXIN RD, FENGXIANG INDUSTRIAL DISTRICT
DALIANG, SHUNDE, FOSHAN,  CN 528300
Correspondent Contact WU TINGJIE
Regulation Number868.2775
Classification Product Code
BXN  
Date Received06/13/2012
Decision Date 03/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-