Clearance Summary
COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D received FDA 510(k) clearance under submission number K080580, sponsored by Axelgaard Mfg. Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2008-06-18.
- Submission: K080580
- Applicant / Sponsor: Axelgaard Mfg. Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5525
- Decision date: 2008-06-18
Classification & Regulation
This clearance is catalogued under FDA product code EGJ and 21 CFR 890.5525, within the Physical Medicine review panel as a Class II device.