510(k) Report

FDA applicant

Dongguan Bohuikang Technology Co.,Ltd

Dongguan, CN1 decision2022–20220 recalls

FDA records 1 decision for Dongguan Bohuikang Technology Co.,Ltd (Dongguan, CN) in 2022: 1 510(k) clearance. All are in product code NUH (Stimulator, Nerve, Transcutaneous…). 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, neurology panel, where it files most

How often FDA has decided Dongguan Bohuikang Technology Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Dongguan Bohuikang Technology Co.,Ltd by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter1decision

What has FDA decided for it lately?

  • K213788TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)Dongguan Bohuikang Technology Co.,Ltd · 2022

The one decision as Dongguan Bohuikang Technology Co.,Ltd →