Panels › Physical Medicine › Product code EGJ · Class 2
Device, Iontophoresis, Other Uses
Regulation 890.5525
0510(k)s in 12 months (73 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in EGJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Empi | 11 | 0 |
| Iomed, Inc. | 11 | 0 |
| Hidrex GmbH | 1 | 3 |
| Life-Tech Intl., Inc. | 4 | 0 |
| Selectivemed Components, Inc. | 3 | 1 |
| Acclarent, Inc. | 3 | 0 |
| Activatek, Inc. | 3 | 0 |
| Dynatronics Corp. | 2 | 0 |
| General Medical Co. | 2 | 0 |
| LTS Therapy Systems, LLC | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2025 | LTS Therapy Systems, LLC IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080;
The IontoPatch is an Iontophoresis transdermal patch. Open, Classified |
EGJ | K992708 |
| Jul 29, 2025 | LTS Therapy Systems, LLC IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch. Open, Classified |
EGJ | K992708 |
| Nov 10, 2021 | Tapemark Company iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min. Terminated |
EGJ | K992708 |
| Feb 22, 2017 | Hidrex GmbH Daavlin Aquex (DAAV1000) Terminated |
EGJ | K133033 |
| Feb 22, 2017 | Hidrex GmbH Hidrex USA DVP1000 Terminated |
EGJ | K133033 |
| Feb 22, 2017 | Hidrex GmbH Hidrex USA DP450 Terminated |
EGJ | K133033 |
| May 6, 2005 | Selectivemed Components Inc Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, Terminated |
EGJ | K031053 |
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