510(k) K103698
K103698 is an FDA 510(k) premarket notification submitted by Tenscare, Ltd. for the device "TENSCARE ITOUCH SURE MODEL ITS". The FDA issued a decision of Substantially Equivalent on June 21, 2011. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Tenscare, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 2011
- Date Received
- December 20, 2010
- 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