The following data is part of a premarket notification filed by Bio-medical Research Corp. with the FDA for Bmr Powerstim.
Device ID | K840149 |
510k Number | K840149 |
Device Name: | BMR POWERSTIM |
Classification | Stimulator, Muscle, Powered |
Applicant | BIO-MEDICAL RESEARCH CORP. 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 | 1984-01-13 |
Decision Date | 1984-01-30 |