The following data is part of a premarket notification filed by Guangzhou Finecure Medical Equipment Co., Ltd with the FDA for Electrode For Urinary Incontinence.
| Device ID | K140265 |
| 510k Number | K140265 |
| Device Name: | ELECTRODE FOR URINARY INCONTINENCE |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD 4TH FLOOR, JINHUI BUILDING, NANHAI BLVD, NANSHAN DISTRICT Shenzhen, CN 518000 |
| Contact | Field Fu |
| Correspondent | Field Fu GUANGZHOU FINECURE MEDICAL EQUIPMENT 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 | 2014-02-03 |
| Decision Date | 2015-01-23 |
| Summary: | summary |