Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K223825 |
Device Name |
Tens & Ems Device |
Applicant |
Shenzhen Jian Feng Electronic Technology Co., Ltd |
#902, 903 Jialingyu Industrial Building, Dapu Road, |
Houting Village, Shajing Town, Baoan District |
Shenzhen,
CN
518104
|
|
Applicant Contact |
Feng Wen |
Correspondent |
Shenzhen Jian Feng Electronic Technology Co., Ltd |
#902, 903 Jialingyu Industrial Building, Dapu Road, |
Houting Village, Shajing Town, Baoan District |
Shenzhen,
CN
518104
|
|
Correspondent Contact |
Feng Wen |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/21/2022 |
Decision Date | 05/09/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Physical Medicine
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|