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FDA 510(k)

US-100 PORTABLE ULTRASOUND THERAPY UNIT

K-Number: K032793 · 2003-10-09

ApplicantIto Co., Ltd.
Decision Date2003-10-09
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

US-100 PORTABLE ULTRASOUND THERAPY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Ito Co., Ltd.. It received FDA 510(k) clearance on 2003-10-09 under 510(k) number K032793. 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 US-100 PORTABLE ULTRASOUND THERAPY UNIT?

US-100 PORTABLE ULTRASOUND THERAPY UNIT is a medical device that received FDA 510(k) clearance on 2003-10-09. The listed applicant is Ito Co., Ltd.. The 510(k) number is K032793.

When did US-100 PORTABLE ULTRASOUND THERAPY UNIT receive FDA 510(k) clearance?

US-100 PORTABLE ULTRASOUND THERAPY UNIT received FDA 510(k) clearance on 2003-10-09, under 510(k) number K032793.

Who is the listed applicant for US-100 PORTABLE ULTRASOUND THERAPY UNIT?

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

What is the FDA product code for US-100 PORTABLE ULTRASOUND THERAPY UNIT?

The FDA product code for US-100 PORTABLE ULTRASOUND THERAPY UNIT is IMI.

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Other records listing Ito 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.

K203525D functionK112520US-101L, US-103SK081943MODEL ES-130K081247TM-400K022846SW-180 SHORTWAVE THERAPY UNITK990787TRIO 300

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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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