Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K153520 |
Device Name |
Electronic Pulse Stimulator |
Applicant |
JKH HEALTH CO.,LTD. |
4-5F, Building 12, Hengmingzhu Ind. Park, |
Tongfuyu Ind. Area, Shajing, Baoan |
Shenzhen,
CN
518104
|
|
Applicant Contact |
Pu Jiang |
Correspondent |
BILL QUANQIN DAI |
1142 S. DIAMOND BAR BLVD, #861 |
Diamond Bar,
CA
91765
|
|
Correspondent Contact |
Bill Quanqin Dai |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/08/2015 |
Decision Date | 05/05/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|