The following data is part of a premarket notification filed by Axelgaard Mfg. Co., Ltd. with the FDA for Pals Platinum Neurostimulation Electrodes.
| Device ID | K132422 |
| 510k Number | K132422 |
| Device Name: | PALS PLATINUM NEUROSTIMULATION ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | AXELGAARD MFG. CO., LTD. 520 INDUSTRIAL WAY Fallbrook, CA 92028 -2244 |
| Contact | Dan P Jeffery |
| Correspondent | Dan P Jeffery AXELGAARD MFG. CO., LTD. 520 INDUSTRIAL WAY Fallbrook, CA 92028 -2244 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-05 |
| Decision Date | 2014-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851913006401 | K132422 | 000 |
| 00856817005420 | K132422 | 000 |
| 00856817005437 | K132422 | 000 |
| 00856817005444 | K132422 | 000 |
| 00856817005451 | K132422 | 000 |
| 00856817005468 | K132422 | 000 |
| 00856817005475 | K132422 | 000 |
| 00856817005482 | K132422 | 000 |
| 00856817005499 | K132422 | 000 |
| 00856817005413 | K132422 | 000 |
| 00856817005406 | K132422 | 000 |
| 00851913006265 | K132422 | 000 |
| 00851913006418 | K132422 | 000 |
| 00851913006241 | K132422 | 000 |
| 00851913006258 | K132422 | 000 |
| 00888912000420 | K132422 | 000 |
| 00888912000437 | K132422 | 000 |
| 00888912341134 | K132422 | 000 |
| 00888912341141 | K132422 | 000 |
| 00851913006135 | K132422 | 000 |
| 00856817005505 | K132422 | 000 |
| 00856817005512 | K132422 | 000 |
| 00856817005529 | K132422 | 000 |
| 00856817005642 | K132422 | 000 |
| 00856817005659 | K132422 | 000 |
| 00856817005666 | K132422 | 000 |
| 00856817005673 | K132422 | 000 |
| 00856817005680 | K132422 | 000 |
| 00856817005697 | K132422 | 000 |
| 00856817005703 | K132422 | 000 |
| 00856817005710 | K132422 | 000 |
| 00856817005635 | K132422 | 000 |
| 00856817005628 | K132422 | 000 |
| 00856817005611 | K132422 | 000 |
| 00856817005536 | K132422 | 000 |
| 00856817005543 | K132422 | 000 |
| 00856817005550 | K132422 | 000 |
| 00856817005567 | K132422 | 000 |
| 00856817005574 | K132422 | 000 |
| 00856817005581 | K132422 | 000 |
| 00856817005598 | K132422 | 000 |
| 00856817005604 | K132422 | 000 |
| 00856817005727 | K132422 | 000 |