Hidrex USA
HIDREX USA DVP1000 Iontophoresis Device Package Hand/Foot (Aluminum Electrode Plates, US Type A Plug)
2manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
3recalls on this code
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 | Hidrex Gmbh, Germany |
|---|---|
| FDA product code | EGJ |
| Device type | Device, Iontophoresis, Other Uses |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5525 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-02-08 |
| Record revised | 2022-11-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DP450 Package HF AL | In distribution | |
| DVP1000 Package HF AL | 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 |
| Ionto480 Buffered Iontophoresis Electrode Treatment Kit | Axelgaard Manufacturing Co., Ltd. | 4 |
| ActivaTek Ionto4 Kit | North Coast Medical, Inc. | 3 |
Showing 12 of 68. All products under Device, Iontophoresis, Other Uses
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133033 | 2015-04-08 |
Recalls
3 of these are Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-01-30 | Class III | Error in labeling | The device was reclassified from a class III device to a class II device and there are new documentation requirements. | 64 units | 2017-08-04 |
| 2017-01-30 | Class III | Error in labeling | The device was reclassified from a class III device to a class II device and there are new documentation requirements. | 180 units | 2017-08-04 |
| 2017-01-30 | Class III | Error in labeling | The device was reclassified from a class III device to a class II device and there are new documentation requirements. | 250 units | 2017-08-04 |
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.