Clearance Summary
Portable Electro-Stimulation Therapy Device received FDA 510(k) clearance under submission number K182020, sponsored by Guangzhou Longest Science & Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2020-09-17.
- Submission: K182020
- Applicant / Sponsor: Guangzhou Longest Science & Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2020-09-17
Classification & Regulation
This clearance is catalogued under FDA product code NGX and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.