510(k) Report

FDA applicant

Shenzhen Dongjilian Electronics Co., Ltd.

Shenzhen, CN3 decisions2020–20200 recalls

FDA records 3 decisions for Shenzhen Dongjilian Electronics Co., Ltd. (Shenzhen, CN) in 2020: 3 510(k) clearances. Most are in product codes IRP (Massager, Powered Inflatable Tube) and NUH (Stimulator, Nerve, Transcutaneous…). Since 2016 its 510(k)s took a median of 150 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 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 Shenzhen Dongjilian Electronics Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2020

2020: 3
2020high 3 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Shenzhen Dongjilian Electronics Co., Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shenzhen Dongjilian Electronics Co.…’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?

  • IRPMassager, Powered Inflatable Tube2decisions
  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 150 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 150 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 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.

  • K193354Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 20209cite it

What has FDA decided for it lately?

  • K201694Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020
  • K200354Electronic stimulatorShenzhen Dongjilian Electronics Co., Ltd. · 2020
  • K193354Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020

All 3 as Shenzhen Dongjilian Electronics Co., Ltd. →