Clearance Summary
E-FIT EF-1280 EMS MACHINE received FDA 510(k) clearance under submission number K133225, sponsored by Fit-Pro Kft , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2014-10-24.
- Submission: K133225
- Applicant / Sponsor: Fit-Pro Kft , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2014-10-24
Classification & Regulation
This clearance is catalogued under FDA product code NGX and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.