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ActivaPatch IontoGo 4.0
ACTIVATEK INC. · Model 001-50 · UDI-DI 00859975005202
EGJ
Prescription
10
510(k) clearances
146
Adverse events
7
Recalls
20
Facilities
Description
ActivaPatch IontoGo 4.0 carton with 6 pouches. 4 hour iontophoresis delivery.
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.