The following data is part of a premarket notification filed by Henley Intl. with the FDA for True-trac, Stratus.
| Device ID | K926316 |
| 510k Number | K926316 |
| Device Name: | TRUE-TRAC, STRATUS |
| Classification | Table, Physical Therapy, Multi Function |
| Applicant | HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Contact | Ernest J Henley |
| Correspondent | Ernest J Henley HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Product Code | JFB |
| CFR Regulation Number | 890.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-15 |
| Decision Date | 1993-03-24 |