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)

IO-DRIVE

K-Number: K993081 · 2000-03-03

ApplicantSelectivemed Components, Inc.
Decision Date2000-03-03
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

IO-DRIVE is the device name listed in this FDA 510(k) record. The listed applicant is Selectivemed Components, Inc.. It received FDA 510(k) clearance on 2000-03-03 under 510(k) number K993081. 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 IO-DRIVE?

IO-DRIVE is a medical device that received FDA 510(k) clearance on 2000-03-03. The listed applicant is Selectivemed Components, Inc.. The 510(k) number is K993081.

When did IO-DRIVE receive FDA 510(k) clearance?

IO-DRIVE received FDA 510(k) clearance on 2000-03-03, under 510(k) number K993081.

Who is the listed applicant for IO-DRIVE?

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

What is the FDA product code for IO-DRIVE?

The FDA product code for IO-DRIVE 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 Selectivemed Components, Inc. 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.

K120922GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNITK083756GUARDIAN 150 ELECTRODEK031053SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7K020476MEDION 6000K946230ENDURA REUSABLE TENS AND NMES ELECTRODESK945676GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES

View all 7 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.

↑