The following data is part of a premarket notification filed by Dynatronics Research Corp. with the FDA for Dynatron 100 Plus.
Device ID | K933249 |
510k Number | K933249 |
Device Name: | DYNATRON 100 PLUS |
Classification | Stimulator, Muscle, Powered |
Applicant | DYNATRONICS RESEARCH CORP. 470 LAWNDALE DRIVE, BUILDING D Salt Lake City, UT 84115 |
Contact | John S Ramey |
Correspondent | John S Ramey DYNATRONICS RESEARCH CORP. 470 LAWNDALE DRIVE, BUILDING D Salt Lake City, UT 84115 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-02 |
Decision Date | 1993-10-08 |