Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K163611 |
Device Name |
Pain Therapy Device |
Applicant |
Guangzhou Xinbo Electronic Co., Ltd. |
2nd Building, Juntuo Industry Park, Xingye Dadao |
Nancun Town, Panyu District |
Guangzhou,
CN
511400
|
|
Applicant Contact |
Sammy Li |
Correspondent |
Guangzhou GLOMED Biological Technology Co., Ltd. |
Suite 306, Kecheng Mansion, No.121 Science Road |
Guangzhou Science Park |
Guangzhou,
CN
510000
|
|
Correspondent Contact |
Cecilia Ceng |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/22/2016 |
Decision Date | 09/19/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|