FDA applicant
Shenzhen Kentro Medical Electronics Co., Ltd.
FDA records 10 decisions for Shenzhen Kentro Medical Electronics Co., Ltd. (Shenzhen, CN) from 2017 to 2024: 10 510(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 186 days from receipt to decision, against 137 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 3 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 Shenzhen Kentro Medical Electronics Co., Ltd.’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 2017.
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