Home › AXELGAARD MANUFACTURING CO., LTD. › Ionto480 Buffered Iontophoresis Electrode Treatment Kit
Ionto480 Buffered Iontophoresis Electrode Treatment Kit
AXELGAARD MANUFACTURING CO., LTD. · Model Ionto480 DDL350 · UDI-DI 00856817005901
EGJ
Prescription
1
510(k) clearances
146
Adverse events
7
Recalls
20
Facilities
Description
A non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-sensitive adhesive intended to be used as an alternative to injection for the transport of ionic-solutions medication through the movement of ions, resulting from an applied electric field to locally administer the medication transcutaneously. It typically consists of a positive and a negative electrode, a reservoir/drug chamber that holds the medication. The reservoir must be filled by the user with drug prior to use. This is a single-use device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-22 | LTS Therapy Systems, LLC | The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device. |
| 2025-05-22 | LTS Therapy Systems, LLC | The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device. |
| 2021-11-10 | Tapemark Company | The dosage information on the pouch is incorrect; the primary carton label is correct. |
| 2017-01-30 | Hidrex GmbH | The device was reclassified from a class III device to a class II device and there are new documentation requirements. |
| 2017-01-30 | Hidrex GmbH | The device was reclassified from a class III device to a class II device and there are new documentation requirements. |
| 2017-01-30 | Hidrex GmbH | The device was reclassified from a class III device to a class II device and there are new documentation requirements. |
| 2005-03-15 | Selectivemed Components Inc | The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.