| Device Type ID | 5057 |
| Device Name | Device, Iontophoresis, Other Uses |
| Regulation Description | Iontophoresis Device. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Physical Medicine |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 890.5525 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | EGJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5057 |
| Device | Device, Iontophoresis, Other Uses |
| Product Code | EGJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Iontophoresis Device. |
| CFR Regulation Number | 890.5525 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACCLARENT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HIDREX GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NORTH COAST MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOTERIX MEDICAL,INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 3 |
Component Incompatible | 1 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Hidrex GmbH | III | Feb-22-2017 |