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FDA 510(k)

Ultrasound Stimulator

K-Number: K240788 · 2025-06-04

ApplicantJkh Health Co., Ltd.
Decision Date2025-06-04
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Ultrasound Stimulator is a medical device manufactured by Jkh Health Co., Ltd.. It received FDA 510(k) clearance on 2025-06-04 under approval number K240788. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultrasound Stimulator?

Ultrasound Stimulator is a medical device that received FDA 510(k) clearance on 2025-06-04. It is manufactured by Jkh Health Co., Ltd.. The 510(k) number is K240788.

When was Ultrasound Stimulator approved by the FDA?

Ultrasound Stimulator received FDA 510(k) clearance on 2025-06-04, under approval number K240788.

What company makes Ultrasound Stimulator?

Ultrasound Stimulator is manufactured by Jkh Health Co., Ltd..

What is the FDA product code for Ultrasound Stimulator?

The FDA product code for Ultrasound Stimulator is IMI.

Related Clinical Trials

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Other Devices by Jkh Health Co., Ltd.

K153520Electronic Pulse Stimulator K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 K200561StimPlus Patch, StimPlus Patch, StimPlus Patch K202839Overlapped Compression Therapy K211050Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 K223541Cold/Hot Compression

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Related Devices (Code: IMI)

K161628JAS Pulse(TM) Ultrasonic TherapyBonutti Research, Inc. K160075Accent XLAlma Lasers, Inc. K161502MC1 PlusGeneral Project S.R.L. K160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , Ltd. K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E Orto K210284ManaSportManamed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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