The following data is part of a premarket notification filed by Solcoor, Inc. with the FDA for Agar 7k Tens Instrument.
| Device ID | K862454 |
| 510k Number | K862454 |
| Device Name: | AGAR 7K TENS INSTRUMENT |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | SOLCOOR, INC. 8150 LEESBURG PIKE, STE.700 Vienna, VA 22180 |
| Contact | Barbara Marsden |
| Correspondent | Barbara Marsden SOLCOOR, INC. 8150 LEESBURG PIKE, STE.700 Vienna, VA 22180 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-27 |
| Decision Date | 1987-03-25 |