Clearance Summary
ASCENDA received FDA 510(k) clearance under submission number K941642, sponsored by American Stair-Glide Corp.. 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 1994-06-13.
- Submission: K941642
- Applicant / Sponsor: American Stair-Glide Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3930
- Decision date: 1994-06-13
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.