Clearance Summary
RP Lite 760R received FDA 510(k) clearance under submission number K163280, sponsored by Mego Afek AC , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2017-01-27.
- Submission: K163280
- Applicant / Sponsor: Mego Afek AC , Ltd.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5650
- Decision date: 2017-01-27
Classification & Regulation
This clearance is catalogued under FDA product code IRP and 21 CFR 890.5650, within the Physical Medicine review panel as a Class II device.