NESS L300
Stimulator, Neuromuscular, External Functional
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
The following data is part of a premarket notification filed by Ness-neuromuscular Electrical Stimulation Systems with the FDA for Ness L300.
Pre-market Notification Details
| Device ID | K053468 |
| 510k Number | K053468 |
| Device Name: | NESS L300 |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS 555 13TH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahn |
| Correspondent | Jonathan S Kahn 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-13 |
| Decision Date | 2006-07-07 |
| Summary: | summary |
Trademark Results [NESS L300]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NESS L300 78915007 3381929 Live/Registered |
BIONESS INC. 2006-06-22 |
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