The following data is part of a premarket notification filed by Dynatronics Corp. with the FDA for Dynatron 550.
Device ID | K941577 |
510k Number | K941577 |
Device Name: | DYNATRON 550 |
Classification | Interferential Current Therapy |
Applicant | DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121 |
Contact | John S Ramey |
Correspondent | John S Ramey DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121 |
Product Code | LIH |
Subsequent Product Code | GZJ |
Subsequent Product Code | IPF |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-31 |
Decision Date | 1995-09-01 |