The following data is part of a premarket notification filed by Guangzhou Finecure Medical Equipment Co., Ltd with the FDA for Urinary Incontinence System.
| Device ID | K142369 |
| 510k Number | K142369 |
| Device Name: | Urinary Incontinence System |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD F19, NO. 1 KESHENG ROAD, BAIYUN TORCH, BUILDING, NO. 1633 BEITAI RAOD,BAIYUN Guangzhou, CN 510040 |
| Contact | Chiping Ma |
| Correspondent | Field Fu Shenzhen Yoyatech Consulting Co.,Ltd 4th Floor, Jinhui Building, Nanhai BLVD, Nanshan District Shenzhen, CN 518000 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-25 |
| Decision Date | 2015-06-17 |
| Summary: | summary |