The following data is part of a premarket notification filed by Axelgaard Mfg. Co., Ltd. with the FDA for Electrical Nerve Stimulation(tens) Electrodes.
| Device ID | K852267 |
| 510k Number | K852267 |
| Device Name: | ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES |
| 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 | 1985-05-28 |
| Decision Date | 1985-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912341110 | K852267 | 000 |
| 00888912341097 | K852267 | 000 |
| 00888912340809 | K852267 | 000 |
| 00888912340793 | K852267 | 000 |