Iontophoresis Dupel Blue Butterfly 2.0 Ml
Catalogue number 199334-001, listed by Empi, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
11510(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 | Empi, United States |
|---|---|
| FDA product code | EGJ |
| Device type | Device, Iontophoresis, Other Uses |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5525 |
| Record published | 2014-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 199334-001 | 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 |
|---|---|
| K072946 | 2007-11-16 |
| K070427 | 2007-05-14 |
| K030395 | 2003-04-08 |
| K991991 | 1999-09-10 |
| K983484 | 1998-12-28 |
| K970491 | 1997-05-30 |
| K915444 | 1994-07-15 |
| K912015 | 1991-11-15 |
| K912014 | 1991-10-28 |
| K903093 | 1990-10-11 |
| K896703 | 1990-02-26 |
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.