Submission Details
| 510(k) Number | K071969 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 17, 2007 |
| Decision Date | October 06, 2008 |
| Days to Decision | 447 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
SEN-4100 ELECTRIC STIMULATOR
Oct 2008
Decision
447d
Days
Class 2
Risk
About This 510(k) Submission
K071969 is an FDA 510(k) clearance for the SEN-4100 ELECTRIC STIMULATOR, a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Nihon Kohden America, Inc. (Foothill Ranch, US). The FDA issued a Cleared decision on October 6, 2008, 447 days after receiving the submission on July 17, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.
Device Classification
| Product Code | GWF — Stimulator, Electrical, Evoked Response |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.1870 |
Manufacturer
Similar Devices — GWF Stimulator, Electrical, Evoked Response
All 138
K252842 · Alphatec Spine, Inc.
· Jan 2026
K243982 · Natus Neurology Incorporated
· Jan 2025
K243495 · Natus Neurology Incorporated
· Dec 2024
K242345 · Quantalx Neuroscience
· Nov 2024
K234092 · Alphatec Spine, Inc.
· Apr 2024
K234080 · Soterix Medical, Inc.
· Mar 2024
More from Nihon Kohden America, Inc.
View all
K113117
· GWQ · Mar 2012
K120485
· OMA · Mar 2012
K092573
· OMA · Jul 2010
K083456
· CCK · Mar 2009
K083271
· MHX · Dec 2008