Clearance Summary
Compression Therapy Device Model LGT-2200SP received FDA 510(k) clearance under submission number K191862, 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 2019-10-29.
- Submission: K191862
- Applicant / Sponsor: Guangzhou Longest Science & Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5650
- Decision date: 2019-10-29
Classification & Regulation
This clearance is catalogued under FDA product code IRP and 21 CFR 890.5650, within the Physical Medicine review panel as a Class II device.