FDA product code EGJ: Device, Iontophoresis, Other Uses
EGJ is the FDA product code for device, iontophoresis, other uses. It is a Class II device, regulated under 21 CFR 890.5525 and reviewed by the Physical Medicine panel. FDA has cleared 73 510(k) submissions under EGJ, 3 in the last five years, from 40 different applicants. The average 510(k) review took 187 days (median 107); 214 days on average over the last three years. FDA has posted 7 recalls for EGJ devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Iontophoresis, Other Uses |
| Device class | Class II |
| Regulation | 21 CFR 890.5525 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
510(k) clearances per year for EGJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 90 |
| 2018 | 1 | 452 |
| 2019 | 1 | 141 |
| 2020 | 1 | 133 |
| 2023 | 1 | 101 |
| 2024 | 1 | 164 |
| 2025 | 1 | 263 |
Compare with all 510(k) review times · Search every EGJ clearance
Top EGJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Empi | 11 | 2007-11-16 |
| Iomed, Inc. | 11 | 2007-02-28 |
| Life-Tech Intl., Inc. | 4 | 1994-07-15 |
| Acclarent, Inc. | 3 | 2015-05-20 |
| Activatek, Inc. | 3 | 2014-02-13 |
35 more applicants have EGJ clearances. See the full list in Caduvo.
Most recent EGJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242041 | Taiwan Medical Electronics Co., Ltd. | STOPWET iontophoresis apparatus (SW01) | 2025-04-01 | 263 |
| K241267 | Hidroxa Medical AB | Hidroxa SE30 | 2024-10-17 | 164 |
| K232020 | Top-Rank Health Care Co., Ltd. | Iontophoresis Electrodes | 2023-10-16 | 101 |
| K192749 | Dermadry Laboratories, Inc. | Dermadry | 2020-02-10 | 133 |
| K191436 | Saalmann Medical GmbH & Co. KG | Saalio | 2019-10-18 | 141 |
Recalls for EGJ devices
7 product recalls in 4 recall events; 3 initiated in the last five years and 2 still open. Most recent: 2025-05-22.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2021 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code EGJ?
EGJ is the FDA product code for device, iontophoresis, other uses. It is a Class II device, regulated under 21 CFR 890.5525 and reviewed by the Physical Medicine panel.
What device class is EGJ?
Class II, regulation 21 CFR 890.5525. Typical premarket route: 510(k).
How long does a 510(k) take for product code EGJ?
Across 73 cleared submissions the average was 187 days from receipt to decision (median 107).
Which companies have the most EGJ clearances?
Empi (11); Iomed, Inc. (11); Life-Tech Intl., Inc. (4); Acclarent, Inc. (3); Activatek, Inc. (3).
Have EGJ devices been recalled?
Yes: 7 product recalls across 4 recall events; the most recent began 2025-05-22.
Next steps
- Run an FDA pathway report with predicate devices for product code EGJ
- Run a recall and safety report across every EGJ manufacturer
- Watch product code EGJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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