The following data is part of a premarket notification filed by Dynatronics Research Corp. with the FDA for Dynatron 850.
| Device ID | K941461 |
| 510k Number | K941461 |
| Device Name: | DYNATRON 850 |
| Classification | Interferential Current Therapy |
| Applicant | DYNATRONICS RESEARCH CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121 |
| Contact | John S Ramey |
| Correspondent | John S Ramey DYNATRONICS RESEARCH CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121 |
| Product Code | LIH |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | IMG |
| Subsequent Product Code | IMI |
| 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 | 1994-03-24 |
| Decision Date | 1995-09-01 |