The following data is part of a premarket notification filed by Solcoor, Inc. with the FDA for Uni-tens Xl Tens.
| Device ID | K861896 |
| 510k Number | K861896 |
| Device Name: | UNI-TENS XL TENS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | SOLCOOR, INC. 1655 N. FT. MYER DR. STE. 700 Arlington, VA 22209 |
| Contact | Barbara Marsden |
| Correspondent | Barbara Marsden SOLCOOR, INC. 1655 N. FT. MYER DR. STE. 700 Arlington, VA 22209 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-16 |
| Decision Date | 1986-09-09 |