510(k) Report

FDA applicant

Intradin (Shanghai) Machinery Co., Ltd.

Shanghai, CN4 decisions2024–20250 recalls

FDA records 4 decisions for Intradin (Shanghai) Machinery Co., Ltd. (Shanghai, CN) from 2024 to 2025: 4 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and ITI (Wheelchair, Powered). Since 2016 its 510(k)s took a median of 86 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 2 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 Intradin (Shanghai) Machinery Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2024: 12025: 3
2024high 3 (2025) · low 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Intradin (Shanghai) Machinery Co., Ltd. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Intradin (Shanghai) Machinery 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?

  • INIVehicle, Motorized 3-Wheeled3decisions
  • ITIWheelchair, Powered1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 86 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 111 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K232692Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)Intradin (Shanghai) Machinery Co., Ltd. · 20242cite it
  • K250027Powered Mobility ScooterIntradin (Shanghai) Machinery Co., Ltd. · 20251cites it

What has FDA decided for it lately?

  • K252590Powered Mobility Scooter (PMS105, GUT177, GCAT047)Intradin (Shanghai) Machinery Co., Ltd. · 2025
  • K243970Portable WheelchairIntradin (Shanghai) Machinery Co., Ltd. · 2025
  • K250027Powered Mobility ScooterIntradin (Shanghai) Machinery Co., Ltd. · 2025
  • K232692Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)Intradin (Shanghai) Machinery Co., Ltd. · 2024

All 4 as Intradin (Shanghai) Machinery Co., Ltd. →