510(k) Report

FDA applicant

J-Tech, Inc.

Midvale, UT5 decisions1991–19960 recalls

FDA records 5 decisions for J-Tech, Inc. (Midvale, UT) from 1991 to 1996: 5 510(k) clearances. Most are in product codes KQX (Goniometer, Ac-Powered) and LBB (Dynamometer, Ac-Powered). Its devices cite 2 predicates, 1 of them its own earlier devices. 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, orthopedic panel, where it files most

How often FDA has decided J-Tech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for J-Tech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like J-Tech, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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