Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K200354 |
Device Name |
Electronic stimulator |
Applicant |
Shenzhen Dongjilian Electronics Co.,Ltd. |
B1/1-5F, Tonglu Industrial Area, Tongxin Community |
Longgang District |
Shenzhen,
CN
518116
|
|
Applicant Contact |
Zhang Hong |
Correspondent |
Shenzhen Reanny Medical Devices Management Consulting Co Ltd |
Room 2012#, Gebu commercial building, Hongxing community, |
Songgang street |
Shenzhen,
CN
518105
|
|
Correspondent Contact |
Reanny Wang |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 02/13/2020 |
Decision Date | 06/29/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|