Ionto480 Buffered Iontophoresis Electrode Treatment Kit
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…
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.
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 | Axelgaard Manufacturing Co., Ltd. |
|---|---|
| FDA product code | EGJ |
| Device type | Device, Iontophoresis, Other Uses |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5525 |
| 510(k) | K080580 |
| Record published | 2014-09-22 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 41 to 80.6 °F; Handling environment temperature 41 to 80.6 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Ionto480 DDM325 | 2.5 cc fill volume | In distribution |
| Ionto480 DDS275 | 1.5 cc fill volume | In distribution |
| Ionto480 DDL350 | 4.0 cc fill volume | In distribution |
| Ionto480 DDB375 | 2.0 cc fill volume | 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 |
| IontoPatch | LTS Therapy Systems, LLC | 4 |
| Dupel Blue | Clearlake-Tech Inc | 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
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.