The following data is part of a premarket notification filed by Empi with the FDA for Tbd, Empi Buffered Iontophoresis Electrodes Mdl. 2.
| Device ID | K912014 |
| 510k Number | K912014 |
| Device Name: | TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2 |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | EMPI 1275 GREY FOX RD. St Paul, MN 55112 |
| Contact | Stacy Mattson |
| Correspondent | Stacy Mattson EMPI 1275 GREY FOX RD. St Paul, MN 55112 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-06 |
| Decision Date | 1991-10-28 |