Company ยท US
Neurometrix, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2022. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JXE | Device, Nerve Conduction Velocity Measurement | 7 |
| GXY | Electrode, Cutaneous | 4 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 2 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 |
| GWL | Amplifier, Physiological Signal | 1 |
| QSQ | Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 18, 2022 | DEN210046 | Quell-FM Neurometrix, Inc. | QSQ |
| Jan 5, 2016 | K152954 | Quell Neurometrix, Inc. | NUH |
| Nov 17, 2014 | K140586 | ASCEND ELECTRODE Neurometrix, Inc. | GXY |
| Jul 3, 2014 | K140333 | ASCEND Neurometrix, Inc. | NUH |
| Jul 2, 2013 | K130919 | SENSUS Neurometrix, Inc. | GZJ |
| Nov 26, 2012 | K121816 | SENSUS ELECTRODE Neurometrix, Inc. | GXY |
| Aug 2, 2012 | K121184 | SENSUS Neurometrix, Inc. | GZJ |
| Sep 3, 2009 | K091155 | ASCEND Neurometrix, Inc. | BXN |
| May 27, 2009 | K083322 | NEUROMETRIX BIOAMPLIFIER Neurometrix, Inc. | GWL |
| Jan 21, 2009 | K083818 | UNIVERSAL ELECTRODES Neurometrix, Inc. | GXY |
| Sep 29, 2008 | K081871 | UNIVERSAL ELECTRODES Neurometrix, Inc. | GXY |
| Apr 25, 2008 | K070109 | NEUROMETRIX ADVANCE Neurometrix, Inc. | JXE |
| Jul 31, 2006 | K060584 | NC-STAT Neurometrix, Inc. | JXE |
| Aug 12, 2004 | K041320 | MODIFICATION TO NC-STAT Neurometrix, Inc. | JXE |
| Jan 17, 2002 | K013459 | MODIFICATION OF NC-STAT Neurometrix, Inc. | JXE |
| Jan 17, 2001 | K003508 | NC-STAT Neurometrix, Inc. | JXE |
| Jun 27, 2000 | K000565 | MODIFICATION TO NC-STAT Neurometrix, Inc. | JXE |
| Oct 2, 1998 | K982359 | NC-STAT Neurometrix, Inc. | JXE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||