Clearance Summary
TRANSAMERICAN TENS received FDA 510(k) clearance under submission number K010782, sponsored by Transamerica Medical Systems. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-04-27.
- Submission: K010782
- Applicant / Sponsor: Transamerica Medical Systems
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2001-04-27
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.