The following data is part of a premarket notification filed by Pivotal Health Solutions with the FDA for Itrac Cervical Traction System.
| Device ID | K131983 |
| 510k Number | K131983 |
| Device Name: | ITRAC CERVICAL TRACTION SYSTEM |
| Classification | Equipment, Traction, Powered |
| Applicant | PIVOTAL HEALTH SOLUTIONS 724 OAKWOOD RD Watertown, SD 57201 |
| Contact | Aaron Tvedt |
| Correspondent | Aaron Tvedt PIVOTAL HEALTH SOLUTIONS 724 OAKWOOD RD Watertown, SD 57201 |
| Product Code | ITH |
| Subsequent Product Code | ILZ |
| Subsequent Product Code | IRS |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-28 |
| Decision Date | 2014-09-10 |
| Summary: | summary |