Clearance Summary
STAIR-LIFT received FDA 510(k) clearance under submission number K981486, sponsored by Garaventa (Canada) , 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 1998-07-01.
- Submission: K981486
- Applicant / Sponsor: Garaventa (Canada) , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3930
- Decision date: 1998-07-01
Classification & Regulation
This clearance is catalogued under FDA product code ING and 21 CFR 890.3930, within the Physical Medicine review panel as a Class II device.