The following data is part of a premarket notification filed by Iomed, Inc. with the FDA for Rh-801, Model Transq.
| Device ID | K925806 |
| 510k Number | K925806 |
| Device Name: | RH-801, MODEL TRANSQ |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | IOMED, INC. 1290 WEST 2320 SOUTH SUITE A Salt Lake City, UT 84119 |
| Contact | Anne T Carter |
| Correspondent | Anne T Carter IOMED, INC. 1290 WEST 2320 SOUTH SUITE A Salt Lake City, UT 84119 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-16 |
| Decision Date | 1994-07-14 |