510(k) Report

FDA applicant

Tru-Trac

Temecula, CA3 decisions1986–19890 recalls

FDA records 3 decisions for Tru-Trac (Temecula, CA) from 1986 to 1989: 3 510(k) clearances. Most are in product codes ITH (Equipment, Traction, Powered) and IKK (System, Isokinetic Testing And Evaluation). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Tru-Trac’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tru-Trac since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tru-Trac by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ITHEquipment, Traction, Powered2decisions
  • IKKSystem, Isokinetic Testing And Evaluation1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K893448Tru Trac Traction TableTru-Trac · 19891cites it

What has FDA decided for it lately?

  • K893448Tru Trac Traction TableTru-Trac · 1989
  • K862579Tru-Trac 3-Dimensional Cervical Traction-TD-9000Tru-Trac · 1986
  • K862780Tru-Kinetics (TM)Tru-Trac · 1986

All 3 as Tru-Trac →