The following data is part of a premarket notification filed by Dynatronics Laser Corp. with the FDA for Dynatron 1120 Eps (electrical Point Stimulator).
| Device ID | K864370 |
| 510k Number | K864370 |
| Device Name: | DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR) |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | DYNATRONICS LASER CORP. 470 LAWNDALE DRIVE, BUILDING D Salt Lake City, UT 84115 |
| Contact | Kelvyn H Cullimore |
| Correspondent | Kelvyn H Cullimore DYNATRONICS LASER CORP. 470 LAWNDALE DRIVE, BUILDING D Salt Lake City, UT 84115 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-05 |
| Decision Date | 1987-04-10 |