Clearance Summary
ActiveCare Home received FDA 510(k) clearance under submission number K160431, sponsored by Medical Compression Systems (Dbn) , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2016-07-13.
- Submission: K160431
- Applicant / Sponsor: Medical Compression Systems (Dbn) , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 2016-07-13
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.