Clearance Summary
CP Relief Wand Rx - TENS/NMES received FDA 510(k) clearance under submission number K252236, sponsored by N & C Holdings, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-08-15.
- Submission: K252236
- Applicant / Sponsor: N & C Holdings, LLC
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2025-08-15
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.