Drionic TM
Drionic Underarm Applicator Modules
2manufacturers in China registered for this device type
15catalogue numbers in this listing
2510(k) clearances naming this product 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 | General Meditech, Inc., China |
|---|---|
| FDA product code | EGJ |
| Device type | Device, Iontophoresis, Other Uses |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5525 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-22 |
| Record revised | 2022-11-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Pair Hand/Foot Devices | 2 | In distribution | |
| Underarm Large Parts Kit | 11 | In distribution | |
| Underarm Modules | 2 | In distribution | |
| Underarm Pads | 4 | In distribution | |
| Hand/Foot Large Parts Kit | 10 | In distribution | |
| Hand-Foot Plates | 4 | In distribution | |
| Hand/Foot Parts Kit | 5 | In distribution | |
| Hand-Foot Pads | 4 | In distribution | |
| Underarm Sweat Stop | In distribution | ||
| LG Alkaline Battery | In distribution | ||
| Underarm Parts Kit | 6 | In distribution | |
| Hand/Foot Sweat Stop | In distribution | ||
| Underarm Straps | 2 | In distribution | |
| Pair Underarm Devices | 2 | In distribution | |
| Pair LG Alkaline Batteries | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Dermadry | Dermadry Laboratories Inc. | 3 |
Showing 12 of 68. All products under Device, Iontophoresis, Other Uses
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K853635 | 1985-12-20 |
| K831320 | 1983-07-19 |
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.