The following data is part of a premarket notification filed by Staodynamics, Inc. with the FDA for 10d (tens Device).
| Device ID | K813283 |
| 510k Number | K813283 |
| Device Name: | 10D (TENS DEVICE) |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | STAODYNAMICS, INC. 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 | 1981-11-23 |
| Decision Date | 1982-02-10 |