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IontoPatch
LTS Therapy Systems, LLC · Model STAT · UDI-DI 10815611020005
1
510(k) clearances
146
Adverse events
7
Recalls
20
Facilities
Description
The IontoPatch contains an innovative self-contained battery that produces an electric current to carry drug molecules non-invasively across the skin and to underlying tissue. There is no need for an external power source. Drug delivery is shut off automatically when the prescribed dosage has been administered. The IontoPatch is single use and disposable. Since there are no external batteries or wires, patients are able to return to their daily activities wearing the patch and receiving time-released iontophoresis.
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. |
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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.