Clearance Summary
SMART TENS, MODEL: D-BC05T received FDA 510(k) clearance under submission number K091045, sponsored by Body Clock Health Care, 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 2009-12-18.
- Submission: K091045
- Applicant / Sponsor: Body Clock Health Care, Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2009-12-18
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.