FDA applicant
J-Tech, Inc.
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
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.
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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