EGJClass II
Device, Iontophoresis, Other Uses
21 CFR 890.5525 / Physical Medicine
EGJ is the FDA product code for Device, Iontophoresis, Other Uses, a class II device type, regulated under 21 CFR 890.5525. As of , FDA records hold 73 510(k) clearances under this code, the most recent dated , and 7 recalls.
Classification record
- Product code
- EGJ
- Device name
- Device, Iontophoresis, Other Uses
- Regulation
- 21 CFR 890.5525
- Device class
- Class II
- Review panel
- Physical Medicine
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 73
- Ingested recalls
- 7
Clearances, product code EGJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 2 |
| 1987 | 3 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 6 |
| 1991 | 4 |
| 1994 | 7 |
| 1995 | 2 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 3 |
| 2002 | 1 |
| 2003 | 5 |
| 2004 | 3 |
| 2005 | 2 |
| 2006 | 4 |
| 2007 | 5 |
| 2008 | 2 |
| 2009 | 2 |
| 2011 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code EGJ| Applicant | Clearances |
|---|---|
| Iomed, Inc. | 11 |
| Empi | 5 |
| Empi | 5 |
| Life-Tech Intl., Inc. | 4 |
| Acclarent Inc | 3 |
| Activatek, Inc. | 3 |
| Spectramed, LLC | 3 |
| Dynatronics Corp. | 2 |
| General Medical Co. | 2 |
| Mattioli Engineering Corp. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
