The following data is part of a premarket notification filed by Biomedical Design Instruments with the FDA for Myopulse.
Device ID | K833928 |
510k Number | K833928 |
Device Name: | MYOPULSE |
Classification | Stimulator, Muscle, Powered |
Applicant | BIOMEDICAL DESIGN INSTRUMENTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-14 |
Decision Date | 1984-12-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MYOPULSE 78054632 2591689 Dead/Cancelled |
Biomedical Development Corp. 2001-03-22 |
MYOPULSE 77903769 3828098 Live/Registered |
Biomedical Development Corporation 2009-12-31 |
MYOPULSE 73559022 1393931 Dead/Cancelled |
NEBRENSKY, ANTHONY H. 1985-09-19 |