The following data is part of a premarket notification filed by Andover Medical, Inc. with the FDA for Neuro Ease.
| Device ID | K831785 |
| 510k Number | K831785 |
| Device Name: | NEURO EASE |
| Classification | Electrode, Cutaneous |
| Applicant | ANDOVER MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-03 |
| Decision Date | 1983-06-30 |