Clearance Summary
Z TECH TRANSCUTANEOUS NEURAL STIMULATION received FDA 510(k) clearance under submission number K965244, sponsored by Z Technologies, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1997-08-27.
- Submission: K965244
- Applicant / Sponsor: Z Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 1997-08-27
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.