Clearance Summary
Palm TENS received FDA 510(k) clearance under submission number K150308, sponsored by Heat IN A Click, 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 2015-10-20.
- Submission: K150308
- Applicant / Sponsor: Heat IN A Click, LLC
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2015-10-20
Classification & Regulation
This clearance is catalogued under FDA product code NUH and 21 CFR 882.5890, within the Neurology review panel as a Class II device.