Clearance Summary
FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS received FDA 510(k) clearance under submission number K133119, sponsored by Arjohuntleigh Polska SP Z.O.O.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-02-28.
- Submission: K133119
- Applicant / Sponsor: Arjohuntleigh Polska SP Z.O.O.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 2014-02-28
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.