Clearance Summary
Portable Electro-Stimulation Therapy Device received FDA 510(k) clearance under submission number K182108, sponsored by Guangzhou Longest Science & Technology Co., 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 2019-04-26.
- Submission: K182108
- Applicant / Sponsor: Guangzhou Longest Science & Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2019-04-26
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.