The following data is part of a premarket notification filed by Neurometrix, Inc. with the FDA for Ascend Electrode.
| Device ID | K140586 |
| 510k Number | K140586 |
| Device Name: | ASCEND ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | NEUROMETRIX, INC. 62 FOURTH AVE. Waltham, MA 02451 |
| Contact | Rainer Maas |
| Correspondent | Rainer Maas NEUROMETRIX, INC. 62 FOURTH AVE. Waltham, MA 02451 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-07 |
| Decision Date | 2014-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851221006049 | K140586 | 000 |
| 20851221006036 | K140586 | 000 |
| 00851221006018 | K140586 | 000 |
| 00851221006636 | K140586 | 000 |
| 00851221006629 | K140586 | 000 |
| 00851221006674 | K140586 | 000 |
| 00851221006667 | K140586 | 000 |
| 00851221006698 | K140586 | 000 |
| 00851221006681 | K140586 | 000 |