The following data is part of a premarket notification filed by Dynatronics Corp. with the FDA for Dynatron Ibox Iontophoresis Device.
| Device ID | K043047 |
| 510k Number | K043047 |
| Device Name: | DYNATRON IBOX IONTOPHORESIS DEVICE |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121 |
| Contact | Ronald J Hatch |
| Correspondent | Ronald J Hatch DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-11-04 |
| Decision Date | 2005-01-07 |
| Summary: | summary |