The following data is part of a premarket notification filed by Ness-neuromuscular Electrical Stimulation Systems with the FDA for Handmaster.
| Device ID | K031900 | 
| 510k Number | K031900 | 
| Device Name: | HANDMASTER | 
| Classification | Stimulator, Neuromuscular, External Functional | 
| Applicant | NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS 555 13TH STREET, N.W. Washington, DC 20004 -1109 | 
| Contact | Jonathan Kahan | 
| Correspondent | Jonathan Kahan NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS 555 13TH STREET, N.W. Washington, DC 20004 -1109 | 
| Product Code | GZI | 
| CFR Regulation Number | 882.5810 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Special | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2003-06-19 | 
| Decision Date | 2003-08-08 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  HANDMASTER  76529179  2909803 Dead/Cancelled | BIONESS INC. 2003-07-14 | 
|  HANDMASTER  76403653  not registered Dead/Abandoned | Mycycle d.o.o. 2002-05-03 | 
|  HANDMASTER  75608159  2367866 Dead/Cancelled | STEINER COMPANY, INC. 1998-12-21 | 
|  HANDMASTER  75426421  not registered Dead/Abandoned | MYCYCLE, d.o.o. 1998-01-30 | 
|  HANDMASTER  74256990  1805045 Dead/Cancelled | STEINER COMPANY, INC. 1992-03-19 |