The following data is part of a premarket notification filed by Dynatronics Corp. with the FDA for Dynatron 125 Ultrasound.
| Device ID | K961250 |
| 510k Number | K961250 |
| Device Name: | DYNATRON 125 ULTRASOUND |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| 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 | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-01 |
| Decision Date | 1996-08-26 |