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 |