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 |