510(k) Report

FDA applicant

Guangzhou Longest Science & Technology Co., Ltd.

Guangzhou, CN6 decisions2019–20210 recalls

FDA records 6 decisions for Guangzhou Longest Science & Technology Co., Ltd. (Guangzhou, CN) from 2019 to 2021: 6 510(k) clearances. Most are in product codes NGX (Stimulator, Muscle, Powered, For Muscle…) and JOW (Sleeve, Limb, Compressible). Since 2016 its 510(k)s took a median of 252 days from receipt to decision, against 207 for FDA’s reviews in the same codes and years. Its devices cite 9 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 Guangzhou Longest Science & Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2019: 22020: 32021: 1
2019high 3 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Guangzhou Longest Science & Technology Co., Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NGXStimulator, Muscle, Powered, For Muscle Conditioning2decisions
  • JOWSleeve, Limb, Compressible1decision
  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter1decision
  • GZIStimulator, Neuromuscular, External Functional1decision
  • IRPMassager, Powered Inflatable Tube1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 252 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 207 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K191862Compression Therapy Device Model LGT-2200SPGuangzhou Longest Science & Technology Co., Ltd. · 20191cites it

What has FDA decided for it lately?

  • K202110MStim Drop Model: LGT-233Guangzhou Longest Science & Technology Co., Ltd. · 2021
  • K201845Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)Guangzhou Longest Science & Technology Co., Ltd. · 2020
  • K182020Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd. · 2020
  • K191856Compression Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd. · 2020
  • K191862Compression Therapy Device Model LGT-2200SPGuangzhou Longest Science & Technology Co., Ltd. · 2019
  • K182108Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd. · 2019

All 6 as Guangzhou Longest Science & Technology Co., Ltd. →