The following data is part of a premarket notification filed by Med General with the FDA for Myo-stim.
Device ID | K781239 |
510k Number | K781239 |
Device Name: | MYO-STIM |
Classification | Stimulator, Muscle, Powered |
Applicant | MED GENERAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-07-20 |
Decision Date | 1978-11-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MYO-STIM 73202685 1141582 Dead/Cancelled |
Med General, Inc. 1979-02-05 |