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  |