Clearance Summary
PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 received FDA 510(k) clearance under submission number K083677, sponsored by Commwell , 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 2009-03-10.
- Submission: K083677
- Applicant / Sponsor: Commwell , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 2009-03-10
Classification & Regulation
This clearance is catalogued under FDA product code DRX and 21 CFR 870.2360, within the Cardiovascular review panel as a Class II device.