Clearance Summary
PAINSHIELD MD received FDA 510(k) clearance under submission number K081075, sponsored by Nano Vibronix , Ltd.. 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 2008-08-22.
- Submission: K081075
- Applicant / Sponsor: Nano Vibronix , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5300
- Decision date: 2008-08-22
Classification & Regulation
This clearance is catalogued under FDA product code PFW and 21 CFR 890.5300, within the Physical Medicine review panel as a Class II device.