510(k) K240788
K240788 is an FDA 510(k) premarket notification submitted by Jkh Health Co., Ltd. for the device "Ultrasound Stimulator". The FDA issued a decision of Substantially Equivalent on June 4, 2025. The device falls under product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300. Jkh Health Co., Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 2025
- Date Received
- March 22, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- Device Class
- Class II
- Regulation Number
- 890.5300
- Review Panel
- PM
- Submission Type