Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K131921 |
Device Name |
ELECTRONIC PULSE STIMULATOR |
Applicant |
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD |
513 PIAZZA DR. |
UNIT B |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
BILL DAI |
Correspondent |
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD |
513 PIAZZA DR. |
UNIT B |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
BILL DAI |
Regulation Number | 882.5890 |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/26/2013 |
Decision Date | 11/15/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|