510(k) Report

FDA applicant

Jiangsu Intco Medical Products Co., Ltd.

Zhenjiang, CN3 decisions2021–20260 recalls

FDA records 3 decisions for Jiangsu Intco Medical Products Co., Ltd. (Zhenjiang, CN) from 2021 to 2026: 3 510(k) clearances. Most are in product codes ITI (Wheelchair, Powered) and INI (Vehicle, Motorized 3-Wheeled). Since 2016 its 510(k)s took a median of 226 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 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 Jiangsu Intco Medical Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 12026 (partial year): 2
2021high 2 (2026) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Jiangsu Intco Medical Products Co., Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Jiangsu Intco Medical Products 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, Powered2decisions
  • INIVehicle, Motorized 3-Wheeled1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 226 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 108 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K202482Y207 Electric WheelchairJiangsu Intco Medical Products Co., Ltd. · 20214cite it

What has FDA decided for it lately?

  • K253257Virgo Mobility Scooter (Virgo-D,Virgo-F)Jiangsu Intco Medical Products Co., Ltd. · 2026
  • K253241Electric Wheelchair (Y207BL)Jiangsu Intco Medical Products Co., Ltd. · 2026
  • K202482Y207 Electric WheelchairJiangsu Intco Medical Products Co., Ltd. · 2021

All 3 as Jiangsu Intco Medical Products Co., Ltd. →