The following data is part of a premarket notification filed by Axelgaard Mfg. Co., Ltd. with the FDA for Everlast Neurostimulation Electrodes 2x 2,model # El2020.
| Device ID | K983741 |
| 510k Number | K983741 |
| Device Name: | EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 |
| Classification | Electrode, Cutaneous |
| Applicant | AXELGAARD MFG. CO., LTD. 1667 S. MISSION RD. Fallbrook, CA 92028 -4115 |
| Contact | Dan P Jeffrey |
| Correspondent | Dan P Jeffrey AXELGAARD MFG. CO., LTD. 1667 S. MISSION RD. Fallbrook, CA 92028 -4115 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-22 |
| Decision Date | 1998-12-18 |