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FDA 510(k)

SONOPULS 590

K-Number: K920983 · 1993-03-09

ApplicantHenley Intl.
Decision Date1993-03-09
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SONOPULS 590 is the device name listed in this FDA 510(k) record. The listed applicant is Henley Intl.. It received FDA 510(k) clearance on 1993-03-09 under 510(k) number K920983. 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 SONOPULS 590?

SONOPULS 590 is a medical device that received FDA 510(k) clearance on 1993-03-09. The listed applicant is Henley Intl.. The 510(k) number is K920983.

When did SONOPULS 590 receive FDA 510(k) clearance?

SONOPULS 590 received FDA 510(k) clearance on 1993-03-09, under 510(k) number K920983.

Who is the listed applicant for SONOPULS 590?

The FDA 510(k) record lists Henley Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONOPULS 590?

The FDA product code for SONOPULS 590 is IMI.

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Other records listing Henley Intl. 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.

K943449NEUROLOGICAL DIAGNOSTIC DEVICESK926278STAIR CLIMBERK926279UPPER BODY EXERCISERK926287EXERCISE BICYCLEK926314HYDRA FITNESS MODEL 311 TOTAL POWERK926313COMPUTERIZED TESTING AND EXERCISE SYSTEMS

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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.

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

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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