Clearance Summary
VERSEO AIR PRESSURE MASSAGER received FDA 510(k) clearance under submission number K092435, sponsored by The American Export Group & International Services. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2010-03-09.
- Submission: K092435
- Applicant / Sponsor: The American Export Group & International Services
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5650
- Decision date: 2010-03-09
Classification & Regulation
This clearance is catalogued under FDA product code IRP and 21 CFR 890.5650, within the Physical Medicine review panel as a Class II device.