The following data is part of a premarket notification filed by Dynatronics Corp. with the FDA for Dynatron Peltier Thermostim Probe.
| Device ID | K132057 |
| 510k Number | K132057 |
| Device Name: | DYNATRON PELTIER THERMOSTIM PROBE |
| Classification | Electrode, Cutaneous |
| Applicant | DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121 |
| Contact | Douglas Sampson |
| Correspondent | Douglas Sampson DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-03 |
| Decision Date | 2014-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10660584000178 | K132057 | 000 |