The following data is part of a premarket notification filed by Henley Intl. with the FDA for Tts2800.
| Device ID | K895161 |
| 510k Number | K895161 |
| Device Name: | TTS2800 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Contact | Ernest Henley |
| Correspondent | Ernest Henley HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-22 |
| Decision Date | 1989-10-30 |