The following data is part of a premarket notification filed by Dynatronics Corp. with the FDA for Dynatron 650.
| Device ID | K950348 |
| 510k Number | K950348 |
| Device Name: | DYNATRON 650 |
| Classification | Interferential Current Therapy |
| Applicant | DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121 |
| Contact | John S Ramey |
| Correspondent | John S Ramey DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121 |
| Product Code | LIH |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | IPF |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-27 |
| Decision Date | 1995-09-13 |