510(k) Report

FDA applicant

Nanjing E-Take Medical Apparatus Co., Ltd.

Nanjing, CN1 decision2024–20240 recalls

FDA records 1 decision for Nanjing E-Take Medical Apparatus Co., Ltd. (Nanjing, CN) in 2024: 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 Nanjing E-Take Medical Apparatus Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Nanjing E-Take Medical Apparatus Co., Ltd. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ITIWheelchair, Powered1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K242989Electric Wheelchair (MODEL H)Nanjing E-Take Medical Apparatus Co., Ltd. · 20242cite it

What has FDA decided for it lately?

  • K242989Electric Wheelchair (MODEL H)Nanjing E-Take Medical Apparatus Co., Ltd. · 2024

The one decision as Nanjing E-Take Medical Apparatus Co., Ltd. →