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FDA 510(k)

SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900

K-Number: K090542 · 2009-10-23

ApplicantSun-Rain System Corp.
Decision Date2009-10-23
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 is the device name listed in this FDA 510(k) record. The listed applicant is Sun-Rain System Corp.. It received FDA 510(k) clearance on 2009-10-23 under 510(k) number K090542. 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 SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900?

SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 is a medical device that received FDA 510(k) clearance on 2009-10-23. The listed applicant is Sun-Rain System Corp.. The 510(k) number is K090542.

When did SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 receive FDA 510(k) clearance?

SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 received FDA 510(k) clearance on 2009-10-23, under 510(k) number K090542.

Who is the listed applicant for SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900?

The FDA 510(k) record lists Sun-Rain System Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900?

The FDA product code for SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 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 Sun-Rain System Corp. 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.

K024013SUN-RAIN ULTRASONIC THERAPY, SU-100K011913SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES

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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