FDA applicant
Hivox Biotek, Inc.
FDA records 18 decisions for Hivox Biotek, Inc. (New Taipei City, TW) from 2002 to 2026: 18 510(k) clearances. Most are in product codes NUH (Stimulator, Nerve, Transcutaneous…) and NGX (Stimulator, Muscle, Powered, For Muscle…). Since 2016 its 510(k)s took a median of 92 days from receipt to decision, against 146 for FDA’s reviews in the same codes and years. Its devices cite 23 predicates, 9 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 Hivox Biotek, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Hivox Biotek, 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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