The following data is part of a premarket notification filed by Empi with the FDA for Empi Action Patch Iontophoresis System.
| Device ID | K030395 |
| 510k Number | K030395 |
| Device Name: | EMPI ACTION PATCH IONTOPHORESIS SYSTEM |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | EMPI 1800 MASSACHUSETTS AVE NW SUITE 200 Washington, DC 20036 -1221 |
| Contact | Susan Onel |
| Correspondent | Susan Onel EMPI 1800 MASSACHUSETTS AVE NW SUITE 200 Washington, DC 20036 -1221 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-05 |
| Decision Date | 2003-04-08 |
| Summary: | summary |