510(k) K122194
K122194 is an FDA 510(k) premarket notification submitted by Everyway Medical Instruments Co.,Ltd for the device "LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE". The FDA issued a decision of Substantially Equivalent on April 4, 2013. 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 Instruments Co.,Ltd has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2013
- Date Received
- July 24, 2012
- 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