Cleared Traditional

Ultrasound Stimulator

K240788 · Jkh Health Co., Ltd. · Physical Medicine

Jun 2025

Decision

439d

Days

Class 2

Risk

About This 510(k) Submission

K240788 is an FDA 510(k) clearance for the Ultrasound Stimulator, 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 review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K240788 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	IMI — Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5300