IMG

Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

Product code
IMG
Device name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device class
Class 2
21 CFR
21 CFR 890.5860
Medical specialty
Physical Medicine
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
55 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-10-07.

NumberDecision dateApplicantDevice nameSummary
K2440412025-10-07Xemis Medical Technology (Shenzhen) Co…Ultrasound Therapy Workstation (XMS-UET2)PDF

1 summaries are archived here for direct download.

Official FDA classification page: IMG
Classification and pathway per current FDA publications. Data from openFDA (CC0).