IMI
- Product code
- IMI
- Device name
- Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- Device class
- Class 2
- 21 CFR
- 21 CFR 890.5300
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 89
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240788 | 2025-06-04 | Jkh Health Co., Ltd. | Ultrasound Stimulator | |
| K230472 | 2023-10-24 | Enraf-Nonius, B.V. | Sonopuls 190 |
Official FDA classification page: IMI
Classification and pathway per current FDA publications. Data from openFDA (CC0).