510(k) K201014
K201014 is an FDA 510(k) premarket notification submitted by Thought Technology , Ltd. for the device "MyOnyx System". The FDA issued a decision of Substantially Equivalent on Jan 13, 2021. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Thought Technology , Ltd. has 21 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 13, 2021
- Date Received
- Apr 17, 2020
- 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)