510(k) K210441
K210441 is an FDA 510(k) premarket notification submitted by Shenzhen Med-Link Electronics Tech Co., Ltd. for the device "Incontinence Probe". The FDA issued a decision of Substantially Equivalent on September 17, 2021. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Shenzhen Med-Link Electronics Tech Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2021
- Date Received
- February 12, 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