Clearance Summary
HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT received FDA 510(k) clearance under submission number K964188, sponsored by Healthcare Service and Supply. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1997-05-06.
- Submission: K964188
- Applicant / Sponsor: Healthcare Service and Supply
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 1997-05-06
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.