Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K192201 |
Device Name |
Electrical Stimulator System |
Applicant |
Gymmax Technology Shenzen Co., Ltd. |
East 5F, A2 Building, Huimingsheng DingFeng Technology Park, |
Fuhai Street, Fuyong Town, Baoan District |
ShenZhen city,
CN
518103
|
|
Applicant Contact |
Benson Wang |
Correspondent |
IMD Medical & Drug technology service institutions |
Tianbao office room 225, Sha Tai Road No.209 |
ShenZhen city,
CN
518117
|
|
Correspondent Contact |
Salon Chen |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/13/2019 |
Decision Date | 06/12/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|