K240788 is an FDA 510(k) clearance for the Ultrasound Stimulator. This device is classified as a Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code IMI).
Submitted by Jkh Health Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 4, 2025, 439 days after receiving the submission on March 22, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5300.
| 510(k) Number | K240788 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2024 |
| Decision Date | June 04, 2025 |
| Days to Decision | 439 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IMI - Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5300 |