The following data is part of a premarket notification filed by Dynatronics Corp. with the FDA for Dynatron 360 Range Of Motion Testing Device.
| Device ID | K897178 |
| 510k Number | K897178 |
| Device Name: | DYNATRON 360 RANGE OF MOTION TESTING DEVICE |
| Classification | Goniometer, Ac-powered |
| Applicant | DYNATRONICS CORP. 470 LAWNDALE DR. BUILDING D Salt Lake City, UT 84115 |
| Contact | H Cullimore |
| Correspondent | H Cullimore DYNATRONICS CORP. 470 LAWNDALE DR. BUILDING D Salt Lake City, UT 84115 |
| Product Code | KQX |
| CFR Regulation Number | 888.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-27 |
| Decision Date | 1990-04-18 |