Clearance Summary
Nu-beca Transcutaneous Electrical Nerve Stimulation received FDA 510(k) clearance under submission number K223151, sponsored by Nu-Beca & Maxcellent Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2023-07-19.
- Submission: K223151
- Applicant / Sponsor: Nu-Beca & Maxcellent Co.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2023-07-19
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.