The following data is part of a premarket notification filed by Everyway Medical Instrument Co., Ltd. with the FDA for Everyway Incontinence Stimulation System.
| Device ID | K161349 |
| 510k Number | K161349 |
| Device Name: | Everyway Incontinence Stimulation System |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | EVERYWAY MEDICAL INSTRUMENT CO., LTD. 3FL., NO. 5, LANE 155, SECTION 3, PEISHEN RD. Shenkeng Dist, New Taipei City, CN 22203 |
| Contact | Robert Tu |
| Correspondent | Robert Tu EVERYWAY MEDICAL INSTRUMENT CO., LTD. 3FL., NO. 5, LANE 155, SECTION 3, PEISHEN RD. Shenkeng Dist, New Taipei City, CN 22203 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-16 |
| Decision Date | 2017-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871189092 | K161349 | 000 |
| 04719871185049 | K161349 | 000 |
| 04719871185025 | K161349 | 000 |
| 04719871184950 | K161349 | 000 |
| 04719871189238 | K161349 | 000 |
| 04719871189108 | K161349 | 000 |