510(k) Report

FDA applicant

Nanjing Kangni Smart Technology Co., Ltd.

Nanjing, CN2 decisions2025–20250 recalls

FDA records 2 decisions for Nanjing Kangni Smart Technology Co., Ltd. (Nanjing, CN) in 2025: 2 510(k) clearances. Most are in product codes ITI (Wheelchair, Powered) and INI (Vehicle, Motorized 3-Wheeled). Its devices cite 2 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, last Nov 3, 2026

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

How often FDA has decided Nanjing Kangni Smart Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2025: 2
2025high 2 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Nanjing Kangni Smart Technology Co., Ltd. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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