510(k) K161349
K161349 is an FDA 510(k) premarket notification submitted by Everyway Medical Instrument Co., Ltd. for the device "Everyway Incontinence Stimulation System". The FDA issued a decision of Substantially Equivalent on Jul 7, 2017. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Everyway Medical Instrument Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 7, 2017
- Date Received
- May 16, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Non-Implantable, For Incontinence
- Device Class
- Class II
- Regulation Number
- 876.5320
- Review Panel
- GU
- Submission Type
- 510(k)