Clearance Summary
B.07 STAIRWAY CHAIRLIFT received FDA 510(k) clearance under submission number K024345, sponsored by Services Industriels Savaria, Inc.. 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 2003-02-26.
- Submission: K024345
- Applicant / Sponsor: Services Industriels Savaria, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5150
- Decision date: 2003-02-26
Classification & Regulation
This clearance is catalogued under FDA product code ILK and 21 CFR 890.5150, within the Physical Medicine review panel as a Class II device.