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FDA 510(k)

COMFORT/IO IONTOPHORESIS ELECTRODES

K-Number: K060579 · 2006-04-20

ApplicantPepin Mfg., Inc.
Decision Date2006-04-20
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COMFORT/IO IONTOPHORESIS ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Pepin Mfg., Inc.. It received FDA 510(k) clearance on 2006-04-20 under 510(k) number K060579. 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 COMFORT/IO IONTOPHORESIS ELECTRODES?

COMFORT/IO IONTOPHORESIS ELECTRODES is a medical device that received FDA 510(k) clearance on 2006-04-20. The listed applicant is Pepin Mfg., Inc.. The 510(k) number is K060579.

When did COMFORT/IO IONTOPHORESIS ELECTRODES receive FDA 510(k) clearance?

COMFORT/IO IONTOPHORESIS ELECTRODES received FDA 510(k) clearance on 2006-04-20, under 510(k) number K060579.

Who is the listed applicant for COMFORT/IO IONTOPHORESIS ELECTRODES?

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

What is the FDA product code for COMFORT/IO IONTOPHORESIS ELECTRODES?

The FDA product code for COMFORT/IO IONTOPHORESIS ELECTRODES 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.

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Other records listing Pepin Mfg., 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.

K070807CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODESK932849PMI TENS ELECTRODE

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.

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