The following data is part of a premarket notification filed by Dynatronics Corp. with the FDA for Dynatron Dx2 Traction Unit.
| Device ID | K051680 |
| 510k Number | K051680 |
| Device Name: | DYNATRON DX2 TRACTION UNIT |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121 |
| Contact | Ron Hatch |
| Correspondent | Ron Hatch DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-23 |
| Decision Date | 2005-10-11 |
| Summary: | summary |