FDA applicant
Dongguan Prestige Sporting Goods Co., Ltd.
FDA records 12 decisions for Dongguan Prestige Sporting Goods Co., Ltd. (Dongguan, CN) from 2013 to 2021: 12 510(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 336 days from receipt to decision, against 278 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Dongguan Prestige Sporting Goods., Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Dongguan Prestige Sporting Goods Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
7in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
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