Cleared Traditional

Compression Therapy Device (LGT-2210DS)

K250244 · Guangzhou Longest Medical Technology Co., Ltd. · Physical Medicine

Jul 2025

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K250244 is an FDA 510(k) clearance for the Compression Therapy Device (LGT-2210DS), a Massager, Powered Inflatable Tube (Class II — Special Controls, product code IRP), submitted by Guangzhou Longest Medical Technology Co., Ltd. (Guanzhou, CN). The FDA issued a Cleared decision on July 25, 2025, 179 days after receiving the submission on January 27, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number	K250244 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 27, 2025
Decision Date	July 25, 2025
Days to Decision	179 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF