FDA applicant

High Country Ent.

Mchenry, IL1 decision1982–19820 recalls

FDA records 1 decision for High Country Ent. (Mchenry, IL) in 1982: 1 510(k) clearance. All are in product code EPF (Hearing Aid, Group And Auditory Trainer). 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, ear, nose and throat panel, where it files most

How often FDA has decided High Country Ent.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for High Country Ent. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “High”

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

High Momentum Sdn Bhd 4 High Technology Products S.L.U 3

High Country Ent.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “High”