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)

INFINITY ELECTROTHERAPY SYSTEM

K-Number: K042057 · 2004-12-17

ApplicantEmpi
Decision Date2004-12-17
Product CodeLIH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INFINITY ELECTROTHERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Empi. It received FDA 510(k) clearance on 2004-12-17 under 510(k) number K042057. The device is classified under product code LIH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITY ELECTROTHERAPY SYSTEM?

INFINITY ELECTROTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2004-12-17. The listed applicant is Empi. The 510(k) number is K042057.

When did INFINITY ELECTROTHERAPY SYSTEM receive FDA 510(k) clearance?

INFINITY ELECTROTHERAPY SYSTEM received FDA 510(k) clearance on 2004-12-17, under 510(k) number K042057.

Who is the listed applicant for INFINITY ELECTROTHERAPY SYSTEM?

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

What is the FDA product code for INFINITY ELECTROTHERAPY SYSTEM?

The FDA product code for INFINITY ELECTROTHERAPY SYSTEM is LIH.

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 Empi 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.

K093324EMPI CONTINUUMK090922EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATORK072946HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEMK070427DUPEL TRANSPORT IONTOPHORESIS SYSTEMK061650SELECT TENS, MODEL 4600SK041920INFINITY PLUS ELECTROTHERAPY SYSTEM

View all 60 devices →

Related Devices (Code: LIH)

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.

K231575Vecttor VT-300Artaflex, Inc.K202725ETD4000Therasigma, LLCK183692Avid IF2Vision Quest Industries Inc./Dba VQ OrthocareK122944GEMORE TRUE SINE INTERFERENTIAL STIMULATORGemore Technology Co, Ltd.K121662VECTTOR VT-200Alan Neuromedical Technologies, LLCK110509EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908Everyway Medical Instruments Co.,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.

↑