Device Classification Name |
stimulator, electrical, non-implantable, for incontinence
|
510(k) Number |
K220161 |
Device Name |
Biofeedback Nerve and Muscle Stimulator |
Applicant |
Shenzhen Konmed Technology Co.,Ltd. |
601, Building B4, Shenchengtou Creative Factory Life |
Science Park, Julongshan A Road |
Shenzhen,
CN
518118
|
|
Applicant Contact |
ShuiShan Yin |
Correspondent |
Guangzhou Glomed Biological Technology Co., Ltd. |
2231, Building 1, Rui Feng Center, Kaichuang Road, |
Huangpu District |
Guangzhou,
CN
510530
|
|
Correspondent Contact |
Cassie Lee |
Regulation Number | 876.5320
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/20/2022 |
Decision Date | 07/20/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|