Clearance Summary
NAUTILUS LEG EXTENSION TESTING & REHABILITATION received FDA 510(k) clearance under submission number K861206, sponsored by Nautilus Sports/Medical Industries, 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 1986-04-18.
- Submission: K861206
- Applicant / Sponsor: Nautilus Sports/Medical Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1925
- Decision date: 1986-04-18
Classification & Regulation
This clearance is catalogued under FDA product code IKK and 21 CFR 890.1925, within the Physical Medicine review panel as a Class II device.