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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 the device name listed in this FDA 510(k) record. The listed applicant is Jkh Health Co., Ltd.. It received FDA 510(k) clearance on 2025-06-04 under 510(k) 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. The listed applicant is Jkh Health Co., Ltd.. The 510(k) number is K240788.

When did Ultrasound Stimulator receive FDA 510(k) clearance?

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

Who is the listed applicant for Ultrasound Stimulator?

The FDA 510(k) record lists Jkh Health Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultrasound Stimulator?

The FDA product code for Ultrasound Stimulator is IMI.

Other records listing Jkh Health Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253150Cryon-X Cold CompressionK240986Cold CompressionK240011Lymphedema CompressionK223541Cold/Hot CompressionK211050Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304K202839Overlapped Compression Therapy

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Related Devices (Code: IMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230472Sonopuls 190Enraf-Nonius, B.V.K222098ManaSport+Manamed, Inc.K210284ManaSportManamed, Inc.K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E OrtoK160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , Ltd.K161628JAS Pulse(TM) Ultrasonic TherapyBonutti Research, 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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