The following data is part of a premarket notification filed by Lead-lok, Inc. with the FDA for Lead-lok Reusable Tens/ Nmes Electrodes.
| Device ID | K010431 |
| 510k Number | K010431 |
| Device Name: | LEAD-LOK REUSABLE TENS/ NMES ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | LEAD-LOK, INC. 500 AIRPORT WAY Sandpoint, ID 83864 |
| Contact | Chris Healy |
| Correspondent | Chris Healy LEAD-LOK, INC. 500 AIRPORT WAY Sandpoint, ID 83864 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-13 |
| Decision Date | 2001-09-06 |