FDA 510(k) information
PelviLift Regulatory Information
Vesdee PelviLift is built on an FDA 510(k)-cleared nonimplanted electrical continence device platform for pelvic floor electrical stimulation and neuromuscular re-education.
FDA 510(k) Reference
- 510(k) number: K213116
- FDA decision date: December 3, 2021
- Regulation: 21 CFR 876.5320
- Regulation name: Nonimplanted Electrical Continence Device
- Regulatory class: Class II
- Product code: KPI
FDA 510(k) clearance means substantial equivalence to a legally marketed predicate device. It is not the same as FDA premarket approval.
Intended Use Context
The referenced device platform is intended to provide electrical stimulation and neuromuscular re-education for rehabilitation of weak pelvic floor muscles in women, including stress, urge, and mixed urinary incontinence support.