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 Number | 868.2775
|
Classification Product Code |
|
Date Received | 06/13/2012 |
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
|
|
|