K241899
- 510(k) number
- K241899
- Device name
- Pelvic Floor Stimulator (Intrelief PFE)
- Applicant
- Easymed Instruments Co., Ltd. CN
- Product code
- KPI — Stimulator, Electrical, Non-Implantable, For Inconti
- Decision date
- 2024-11-27
- Date received
- 2024-06-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K241899
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.