Clearance Summary
STEPMILL EXERCISE SYSTEM received FDA 510(k) clearance under submission number K926170, sponsored by Stairmaster Sports/Medical Products, 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 1993-03-31.
- Submission: K926170
- Applicant / Sponsor: Stairmaster Sports/Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5360
- Decision date: 1993-03-31
Classification & Regulation
This clearance is catalogued under FDA product code ISD and 21 CFR 890.5360, within the Physical Medicine review panel as a Class II device.