Clearance Summary
MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001 received FDA 510(k) clearance under submission number K041101, sponsored by Medical Adhesiveonline, LLC. 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 2004-07-07.
- Submission: K041101
- Applicant / Sponsor: Medical Adhesiveonline, LLC
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5525
- Decision date: 2004-07-07
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.