FDA 510(k)

COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D

K-Number: K080580 · 2008-06-18

Decision Date2008-06-18

Product CodeEGJ

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D is the device name listed in this FDA 510(k) record. The listed applicant is Axelgaard Mfg. Co., Ltd.. It received FDA 510(k) clearance on 2008-06-18 under 510(k) number K080580. 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 IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D?

COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D is a medical device that received FDA 510(k) clearance on 2008-06-18. The listed applicant is Axelgaard Mfg. Co., Ltd.. The 510(k) number is K080580.

When did COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D receive FDA 510(k) clearance?

COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D received FDA 510(k) clearance on 2008-06-18, under 510(k) number K080580.

Who is the listed applicant for COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D?

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

What is the FDA product code for COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D?

The FDA product code for COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D is EGJ.

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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.