COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D— 510(k) K080580

Name: FDA 510(k) clearance K080580
Creator: U.S. Food and Drug Administration
Published: 2008-06-18

Substantially Equivalent

Axelgaard Mfg. Co., Ltd.

FDA 510(k) clearance K080580 for COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D, Substantially Equivalent on 2008-06-18. Applicant: Axelgaard Mfg. Co., Ltd.. Device class: 2.

Clearance details

Applicant: Axelgaard Mfg. Co., Ltd.
Product code: Code EGJ
Device class: Class 2
Regulation: 21 CFR 890.5525
Advisory panel: Physical Medicine
Date received: 2008-03-03
Decision date: 2008-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fallbrook, CA, US

Download summary PDF View on FDA.gov ↗

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