510(k) Report

FDA applicant

Zhejiang Shimo Technology Co., Ltd.

Yongkang, CN1 decision2026–20260 recalls

FDA records 1 decision for Zhejiang Shimo Technology Co., Ltd. (Yongkang, CN) in 2026: 1 510(k) clearance. All are in product code ITI (Wheelchair, Powered). 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 Zhejiang Shimo Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026 (partial year): 1
2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

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

See the 510(k) Report

Which product codes does it file in?

  • ITIWheelchair, Powered1decision

What has FDA decided for it lately?

  • K262652Electric Wheelchair (CN501)Zhejiang Shimo Technology Co., Ltd. · 2026

The one decision as Zhejiang Shimo Technology Co., Ltd. →