Clearance Summary
REBOX II (TENS) received FDA 510(k) clearance under submission number K895183, sponsored by Rebox (Uk) , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1990-01-19.
- Submission: K895183
- Applicant / Sponsor: Rebox (Uk) , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 1990-01-19
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.