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)

SW-180 SHORTWAVE THERAPY UNIT

K-Number: K022846 · 2003-01-28

ApplicantIto Co., Ltd.
Decision Date2003-01-28
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SW-180 SHORTWAVE 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 2003-01-28 under 510(k) number K022846. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SW-180 SHORTWAVE THERAPY UNIT?

SW-180 SHORTWAVE THERAPY UNIT is a medical device that received FDA 510(k) clearance on 2003-01-28. The listed applicant is Ito Co., Ltd.. The 510(k) number is K022846.

When did SW-180 SHORTWAVE THERAPY UNIT receive FDA 510(k) clearance?

SW-180 SHORTWAVE THERAPY UNIT received FDA 510(k) clearance on 2003-01-28, under 510(k) number K022846.

Who is the listed applicant for SW-180 SHORTWAVE 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 SW-180 SHORTWAVE THERAPY UNIT?

The FDA product code for SW-180 SHORTWAVE THERAPY UNIT is IMJ.

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 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-400K032793US-100 PORTABLE ULTRASOUND THERAPY UNITK990787TRIO 300

View all 8 devices →

Related Devices (Code: IMJ)

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.

K252963BTL-899TTBTL Industries, Inc.K250376ViVYViatherm Therapeutics, LLCK243112Curapuls 670Enraf-Nonius, B.V.K223620Reprieve by RegenesisTMRegenesis Biomedical, Inc.K182363BTL-703BTL Industries, Inc.K173300ViaTherm BOOSTViatherm Therapeutics, LLC

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.

↑