Clearance Summary
PORTABLE ISOKINETICS 3002 ISO KANE II received FDA 510(k) clearance under submission number K862994, sponsored by Kent Design & Manufacturing, 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 1986-08-20.
- Submission: K862994
- Applicant / Sponsor: Kent Design & Manufacturing, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1925
- Decision date: 1986-08-20
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.