510(k) Report

FDA applicant

Shenzhen Healthcare Electronic Technology Co., Ltd.

Echo, OR3 decisions2011–20120 recalls

FDA records 3 decisions for Shenzhen Healthcare Electronic Technology Co., Ltd. (Echo, OR) from 2011 to 2012: 3 510(k) clearances. All are in product code MNW (Analyzer, Body Composition). 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, cardiovascular panel, where it files most

How often FDA has decided Shenzhen Healthcare Electronic Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2011: 22012: 1
2011high 2 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Shenzhen Healthcare Electronic Technology Co., Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MNWAnalyzer, Body Composition3decisions

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 2 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.

  • K110928Body Analysis Scale, Model BG 17Shenzhen Healthcare Electronic Technology Co., Ltd. · 20112cite it

What has FDA decided for it lately?

  • K121527WI-FI Body ScaleShenzhen Healthcare Electronic Technology Co., Ltd. · 2012
  • K112951Body Analysis ScaleShenzhen Healthcare Electronic Technology Co., Ltd. · 2011
  • K110928Body Analysis Scale, Model BG 17Shenzhen Healthcare Electronic Technology Co., Ltd. · 2011

All 3 as Shenzhen Healthcare Electronic Technology Co., Ltd. →