510(k) Report

FDA applicant

Lerado China Limited

Hsin-Chu City, TW6 decisions2005–20070 recalls

FDA records 6 decisions for Lerado China Limited (Hsin-Chu City, TW) from 2005 to 2007: 6 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and ITI (Wheelchair, Powered). Its devices cite 7 predicates, 2 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 Lerado China Limited’s devices, and how often a recall has named them.

FDA decisions per year

3in 2007

2007: 3
2007high 3 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lerado China Limited by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lerado China Limited’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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Which product codes does it file in?

  • INIVehicle, Motorized 3-Wheeled5decisions
  • ITIWheelchair, Powered1decision

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 2 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.

  • K051538Avanticare, Model SA4022Lerado China Limited · 20058cite it
  • K070433Lerado, Power Wheelchair, PBLerado China Limited · 20071cites it

What has FDA decided for it lately?

  • K070817Leradotech Scooter, Model SBLerado China Limited · 2007
  • K070802Leradotech, Model SCLerado China Limited · 2007
  • K070433Lerado, Power Wheelchair, PBLerado China Limited · 2007
  • K060068Avanticare, Model SA4021Lerado China Limited · 2006
  • K051473Leardo, Avanticare Electrical SCOOTERSM3021Lerado China Limited · 2005
  • K051538Avanticare, Model SA4022Lerado China Limited · 2005

All 6 as Lerado China Limited →

Other applicant names beginning “Lerado”

FDA records each applicant name separately; these may or may not be the same firm.

Lerado Oversea Ltd. Twn Branch (Bvi) 4Lerado Zhongshan Peaceful Cove Business Trading Co.… 1Lerado Global (Macao Commercial Offshore) Limited 1