The following data is part of a premarket notification filed by Axelgaard Mfg. Co., Ltd. with the FDA for Tens Pals Plus.
| Device ID | K872976 |
| 510k Number | K872976 |
| Device Name: | TENS PALS PLUS |
| Classification | Electrode, Cutaneous |
| Applicant | AXELGAARD MFG. CO., LTD. 2302 MARTIN ST. SUITE 320 Irvine, CA 92715 |
| Contact | Walter A Hackler |
| Correspondent | Walter A Hackler AXELGAARD MFG. CO., LTD. 2302 MARTIN ST. SUITE 320 Irvine, CA 92715 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-30 |
| Decision Date | 1987-09-22 |