IontoPatch
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…
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.
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Top-rank Health Care Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| General Meditech, Inc. | Shenzhen | Guangdong | Complaint-file establishment | 3 |
Record
| Listed by | LTS Therapy Systems, LLC, United States |
|---|---|
| FDA product code | EGJ |
| Device type | Device, Iontophoresis, Other Uses |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5525 |
| Establishment | Manufacturer |
| 510(k) | K992708 |
| Record published | 2016-10-03 |
| Record revised | 2023-12-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 80 | In distribution | |
| STAT | In distribution | |
| SP | In distribution | |
| Extra Strength | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drionic TM | General Meditech, Inc. | 15 |
| Chattanooga | DJO, LLC | 13 |
| Richmar | South Dakota Partners | 12 |
| BodyMed Iontophoresis Electrode Kit | Drive DeVilbiss Healthcare | 8 |
| Trivarion | Activatek, Inc. | 4 |
| Norco | Activatek, Inc. | 4 |
| Performa | Performance Health Supply, Inc. | 4 |
| BodyMed | Boxout, LLC | 4 |
| Dupel Blue | Clearlake-Tech Inc | 4 |
| Ionto480 Buffered Iontophoresis Electrode Treatment Kit | Axelgaard Manufacturing Co., Ltd. | 4 |
| ActivaTek Ionto4 Kit | North Coast Medical, Inc. | 3 |
| Dermadry | Dermadry Laboratories Inc. | 3 |
Showing 12 of 68. All products under Device, Iontophoresis, Other Uses
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| LTS Therapy Systems, LLC | 510(k) number | 2025-05-22 | Class II | Under Investigation by firm | The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device. | 80928 units | |
| LTS Therapy Systems, LLC | 510(k) number | 2025-05-22 | Class II | Under Investigation by firm | The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device. | 63936 units | |
| LTS Therapy Systems, LLC | 510(k) number | 2021-11-10 | Class III | Labeling Change Control | The dosage information on the pouch is incorrect; the primary carton label is correct. | 5,141 primary cartons | 2023-02-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.