The following data is part of a premarket notification filed by Axelgaard Mfg. Co., Ltd. with the FDA for Transcutaneous Electric Nerve Stimulation (tens).
| Device ID | K874469 |
| 510k Number | K874469 |
| Device Name: | TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) |
| Classification | Electrode, Cutaneous |
| Applicant | AXELGAARD MFG. CO., LTD. 104 WEST ELDER ST. Fallbrook, CA 92028 |
| Contact | Walter A Hackler |
| Correspondent | Walter A Hackler AXELGAARD MFG. CO., LTD. 104 WEST ELDER ST. Fallbrook, CA 92028 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-02 |
| Decision Date | 1988-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861039000368 | K874469 | 000 |
| 00888912340984 | K874469 | 000 |
| 00888912340960 | K874469 | 000 |
| 00888912340946 | K874469 | 000 |
| 00888912340922 | K874469 | 000 |
| 00888912340786 | K874469 | 000 |
| 00888912340779 | K874469 | 000 |
| 00888912340762 | K874469 | 000 |
| 00888912340755 | K874469 | 000 |
| 00888912023573 | K874469 | 000 |
| 00888912023566 | K874469 | 000 |
| 10858184006458 | K874469 | 000 |
| 00888912341035 | K874469 | 000 |
| 00888912341042 | K874469 | 000 |
| 00888912341059 | K874469 | 000 |
| 00861039000351 | K874469 | 000 |
| 00861039000344 | K874469 | 000 |
| 00861039000337 | K874469 | 000 |
| 00861039000320 | K874469 | 000 |
| 00861039000313 | K874469 | 000 |
| 00861039000306 | K874469 | 000 |
| 00858184006079 | K874469 | 000 |
| 20858184006455 | K874469 | 000 |
| 00888912341080 | K874469 | 000 |
| 00888912341073 | K874469 | 000 |
| 00888912341066 | K874469 | 000 |
| 10660584000406 | K874469 | 000 |