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FDA 510(k)

HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)

K-Number: K050410 · 2005-07-14

ApplicantHwang Sun Enterprise Co., Ltd.
Decision Date2005-07-14
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ) is the device name listed in this FDA 510(k) record. The listed applicant is Hwang Sun Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2005-07-14 under 510(k) number K050410. 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 HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)?

HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ) is a medical device that received FDA 510(k) clearance on 2005-07-14. The listed applicant is Hwang Sun Enterprise Co., Ltd.. The 510(k) number is K050410.

When did HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ) receive FDA 510(k) clearance?

HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ) received FDA 510(k) clearance on 2005-07-14, under 510(k) number K050410.

Who is the listed applicant for HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)?

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

What is the FDA product code for HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)?

The FDA product code for HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ) is IMI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hwang Sun Enterprise 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.

K040798HES ULTRASONIC THERAPY APPLIANCE

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.

K240788Ultrasound StimulatorJkh Health Co., Ltd.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.

Official Source

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

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