Clearance Summary
MEDAID DUAL CHANNEL TENS received FDA 510(k) clearance under submission number K834334, sponsored by Par Medex , 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 1984-02-13.
- Submission: K834334
- Applicant / Sponsor: Par Medex , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 1984-02-13
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.