510(k) Report

FDA applicant

Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.

Suzhou, CN3 decisions2023–20260 recalls

FDA records 3 decisions for Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. (Suzhou, CN) from 2023 to 2026: 3 510(k) clearances. All are in product code INI (Vehicle, Motorized 3-Wheeled). Since 2016 its 510(k)s took a median of 76 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 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, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 12026 (partial year): 2
2023high 2 (2026) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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