The following data is part of a premarket notification filed by Backtrac with the FDA for Backtrac 90-90 Traction.
| Device ID | K802869 |
| 510k Number | K802869 |
| Device Name: | BACKTRAC 90-90 TRACTION |
| Classification | Component, Traction, Non-invasive |
| Applicant | BACKTRAC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KQZ |
| CFR Regulation Number | 888.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-14 |
| Decision Date | 1980-12-11 |