Clearance Summary
GARAVENTA X3 INCLINED PLATFORM LIFT received FDA 510(k) clearance under submission number K122206, sponsored by Garaventa (Canada) Ltd [Dba Garaventa Lift]. 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 2013-03-21.
- Submission: K122206
- Applicant / Sponsor: Garaventa (Canada) Ltd [Dba Garaventa Lift]
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3930
- Decision date: 2013-03-21
Classification & Regulation
This clearance is catalogued under FDA product code PCE and 21 CFR 890.3930, within the Physical Medicine review panel as a Class II device.