Dermadry
Dermadry is a tap-water iontophoresis device intended to treat excessive sweating of the hands, feet and underarms. It applies low-level direct current between the treatment areas. The…
Dermadry is a tap-water iontophoresis device intended to treat excessive sweating of the hands, feet and underarms. It applies low-level direct current between the treatment areas.
The filing describes hands and feet placed in tap-water electrode baths, while underarm treatment uses electrode pads. The record lists separate hands-and-feet, total and underarm configurations.
Listed Item
DERMADRY TOTAL Tap Water Iontophoresis Device for treatment of hands, feet and underarms
Scope of Use
The filing lists home use and prescription-only status. For hand or foot treatment, electrodes are covered in a towel immersed in tap water.
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 | Dermadry Laboratories Inc., Canada |
|---|---|
| FDA product code | EGJ |
| Device type | Device, Iontophoresis, Other Uses |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5525 |
| Establishment | Manufacturer |
| 510(k) | K192749 |
| Record published | 2020-03-17 |
| Record revised | 2023-07-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 0.7 to 1.06 KiloPascal; Storage environment atmospheric pressure 0.7 to 1.06 KiloPascal; Handling environment humidity 30 to 70 % RH; Storage environment humidity 30 to 70 % RH; Handling environment temperature 10 to 30 °C; Storage environment temperature -25 to 70 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HANDS AND FEET | In distribution | |
| TOTAL | In distribution | |
| UNDERARMS | 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 |
|---|---|
| K192749 | 2020-02-10 |
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.