IMG
- 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)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K244041 | 2025-10-07 | Xemis Medical Technology (Shenzhen) Co… | Ultrasound Therapy Workstation (XMS-UET2) |
Official FDA classification page: IMG
Classification and pathway per current FDA publications. Data from openFDA (CC0).