Cleared Traditional

Ultrasound Therapy Workstation (XMS-UET2)

K244041 · Xemis Medical Technology (Shenzhen) Co., Ltd. · Physical Medicine

Oct 2025

Decision

281d

Days

Class 2

Risk

About This 510(k) Submission

K244041 is an FDA 510(k) clearance for the Ultrasound Therapy Workstation (XMS-UET2), a Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMG), submitted by Xemis Medical Technology (Shenzhen) Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 7, 2025, 281 days after receiving the submission on December 30, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K244041 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 30, 2024
Decision Date	October 07, 2025
Days to Decision	281 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	IMG — Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5860