FDA applicant
Suzhou Master Machinery Manufacturing Co.,Ltd
FDA records 6 decisions for Suzhou Master Machinery Manufacturing Co.,Ltd (Kunshan, CN) from 2023 to 2026: 6 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and ITI (Wheelchair, Powered). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 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
How often FDA has decided Suzhou Master Machinery Manufacturing Co.,Ltd’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
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