510(k) K213133
K213133 is an FDA 510(k) premarket notification submitted by Oriental Inspiration Limited for the device "Keffort (MC-100, MC-100A)". The FDA issued a decision of Substantially Equivalent on April 13, 2022. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Oriental Inspiration Limited has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2022
- Date Received
- September 27, 2021
- 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