Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K182203 |
Device Name |
JKH Stimulator Plus |
Applicant |
JKH USA, LLC |
1142 S. Diamond Bar Blvd, #861 |
Diamond Bar,
CA
91765
|
|
Applicant Contact |
Bill Quanqin Dai |
Correspondent |
JKH USA, LLC |
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 | 08/15/2018 |
Decision Date | 03/14/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|