Clearance Summary
SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM received FDA 510(k) clearance under submission number K060150, sponsored by Andante Medical Devices , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2006-02-23.
- Submission: K060150
- Applicant / Sponsor: Andante Medical Devices , Ltd.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5575
- Decision date: 2006-02-23
Classification & Regulation
This clearance is catalogued under FDA product code IRN and 21 CFR 890.5575, within the Physical Medicine review panel as a Class II device.