The following data is part of a premarket notification filed by Dynatronics Corp. with the FDA for Dynatron X3 , Dynatron Xp Ir Light Pad, D405 Ir Light Probe.
| Device ID | K051261 |
| 510k Number | K051261 |
| Device Name: | DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE |
| Classification | Lamp, Infrared, Therapeutic Heating |
| 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 | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-16 |
| Decision Date | 2005-07-25 |
| Summary: | summary |