510(k) Report

FDA applicant

Shenzhen Jiantuo Electronics Co., Ltd.

Shenzhen, CN3 decisions2025–20250 recalls

FDA records 3 decisions for Shenzhen Jiantuo Electronics Co., Ltd. (Shenzhen, CN) in 2025: 3 510(k) clearances. All are in product code NUH (Stimulator, Nerve, Transcutaneous…). Since 2016 its 510(k)s took a median of 93 days from receipt to decision, against 119 for FDA’s reviews in the same codes and years. 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, neurology panel, where it files most

How often FDA has decided Shenzhen Jiantuo Electronics Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2025: 3
2025high 3 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Shenzhen Jiantuo Electronics Co., Ltd. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shenzhen Jiantuo Electronics Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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