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 |