510(k) Report

FDA applicant

Innovamed Health, LLC

North Salt Lake, UT2 decisions2014–20190 recalls

FDA records 2 decisions for Innovamed Health, LLC (North Salt Lake, UT) from 2014 to 2019: 2 510(k) clearances. All are in product code JOW (Sleeve, Limb, Compressible). Its devices cite 6 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, cardiovascular panel, where it files most

How often FDA has decided Innovamed Health, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2014: 12019: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Innovamed Health, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Innovamed Health, LLC’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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Other applicant names beginning “Innovamed”

FDA records each applicant name separately; these may or may not be the same firm.