The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Smartbrace Electrode.
| Device ID | K940012 |
| 510k Number | K940012 |
| Device Name: | SMARTBRACE ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
| Contact | Kirby J Kuhlemeier |
| Correspondent | Kirby J Kuhlemeier MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-04 |
| Decision Date | 1994-12-05 |