The following data is part of a premarket notification filed by Empi with the FDA for Transcutaneous Elec. Nerve Stimulator.
| Device ID | K813501 |
| 510k Number | K813501 |
| Device Name: | TRANSCUTANEOUS ELEC. NERVE STIMULATOR |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | EMPI 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-14 |
| Decision Date | 1981-12-29 |