The following data is part of a premarket notification filed by Consolidated Medical Equipment, Inc. with the FDA for Post-op Electrode (tens Electrode).
| Device ID | K820082 |
| 510k Number | K820082 |
| Device Name: | POST-OP ELECTRODE (TENS ELECTRODE) |
| Classification | Electrode, Cutaneous |
| Applicant | CONSOLIDATED MEDICAL EQUIPMENT, 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 | 1982-01-12 |
| Decision Date | 1982-01-28 |