Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

US-101L, US-103S

K-Number: K112520 · 2011-10-26

ApplicantIto Co., Ltd.
Decision Date2011-10-26
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

US-101L, US-103S 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 2011-10-26 under 510(k) number K112520. 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-101L, US-103S?

US-101L, US-103S is a medical device that received FDA 510(k) clearance on 2011-10-26. The listed applicant is Ito Co., Ltd.. The 510(k) number is K112520.

When did US-101L, US-103S receive FDA 510(k) clearance?

US-101L, US-103S received FDA 510(k) clearance on 2011-10-26, under 510(k) number K112520.

Who is the listed applicant for US-101L, US-103S?

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-101L, US-103S?

The FDA product code for US-101L, US-103S is IMI.

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 functionK081943MODEL ES-130K081247TM-400K032793US-100 PORTABLE ULTRASOUND THERAPY UNITK022846SW-180 SHORTWAVE THERAPY UNITK990787TRIO 300

View all 8 devices →

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.

↑