510(k) Report

FDA applicant

Skylark Device Co., Ltd.

Taipei, Taiwan, R.O.C., TW20 decisions1991–19990 recalls

FDA records 20 decisions for Skylark Device Co., Ltd. (Taipei, Taiwan, R.O.C., TW) from 1991 to 1999: 20 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and LIH (Interferential Current Therapy). 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, neurology panel, where it files most

How often FDA has decided Skylark Device Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Skylark Device Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Skylark Device Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Skylark”

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