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FDA 510(k)

IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)

K-Number: K000574 · 2000-08-09

ApplicantWr Medical Electronics Co.
Decision Date2000-08-09
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) is the device name listed in this FDA 510(k) record. The listed applicant is Wr Medical Electronics Co.. It received FDA 510(k) clearance on 2000-08-09 under 510(k) number K000574. 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 IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)?

IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) is a medical device that received FDA 510(k) clearance on 2000-08-09. The listed applicant is Wr Medical Electronics Co.. The 510(k) number is K000574.

When did IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) receive FDA 510(k) clearance?

IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) received FDA 510(k) clearance on 2000-08-09, under 510(k) number K000574.

Who is the listed applicant for IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)?

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

What is the FDA product code for IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)?

The FDA product code for IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) is EGJ.

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Other records listing Wr Medical Electronics Co. as applicant

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K092809HRV ACQUIREK063560HILGER DUAL-STIM NERVE STIMULATORK992874Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEMK910624CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4K895838BRACKMANN EMG MONITORING SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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