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)

DUPEL IONTOPHORESIS DEVICE

K-Number: K915444 · 1994-07-15

ApplicantEmpi
Decision Date1994-07-15
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DUPEL IONTOPHORESIS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Empi. It received FDA 510(k) clearance on 1994-07-15 under 510(k) number K915444. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUPEL IONTOPHORESIS DEVICE?

DUPEL IONTOPHORESIS DEVICE is a medical device that received FDA 510(k) clearance on 1994-07-15. The listed applicant is Empi. The 510(k) number is K915444.

When did DUPEL IONTOPHORESIS DEVICE receive FDA 510(k) clearance?

DUPEL IONTOPHORESIS DEVICE received FDA 510(k) clearance on 1994-07-15, under 510(k) number K915444.

Who is the listed applicant for DUPEL IONTOPHORESIS DEVICE?

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 DUPEL IONTOPHORESIS DEVICE?

The FDA product code for DUPEL IONTOPHORESIS DEVICE is EGJ.

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: EGJ)

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.

K242041STOPWET iontophoresis apparatus (SW01)Taiwan Medical Electronics Co., Ltd.K241267Hidroxa SE30Hidroxa Medical ABK232020Iontophoresis ElectrodesTop-Rank Health Care Co., Ltd.K192749DermadryDermadry Laboratories, Inc.K191436SaalioSaalmann Medical GmbH & Co. KGK170835Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITEHightech Development

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.

↑