FDA applicant

Harmony Hill International

Taipei, TW1 decision2013–20130 recalls

FDA records 1 decision for Harmony Hill International (Taipei, TW) in 2013: 1 510(k) clearance. All are in product code IOR (Wheelchair, Mechanical). Its devices cite 1 predicate, 0 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, physical medicine panel, where it files most

How often FDA has decided Harmony Hill International’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Harmony Hill International by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Harmony”

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

Harmony Hearing Aids, Co. 1

Harmony Hill International

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Harmony”