Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K220005 |
Device Name |
TENS & PMS Unit |
Applicant |
Shenzhen Yuehua Xinsen Technology Co., Ltd. |
No. 27-201, Zhongwu 3rd Road, Zhongwu Community, |
Hangcheng Street, Bao’an District |
Shenzhen,
CN
518128
|
|
Applicant Contact |
Evin Li |
Correspondent |
Guangdong Jianda Medical Technology Co., Ltd. |
906 Room, Longxiang Garden, Tianhe district |
Guangzhou,
CN
|
|
Correspondent Contact |
Iris Fung |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/04/2022 |
Decision Date | 04/01/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|