510(k) Report

FDA applicant

Guangzhou Xinbo Electronic Co., Ltd.

Guangzhou, CN12 decisions2017–20240 recalls

FDA records 12 decisions for Guangzhou Xinbo Electronic Co., Ltd. (Guangzhou, CN) from 2017 to 2024: 12 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and NGX (Stimulator, Muscle, Powered, For Muscle…). Since 2016 its 510(k)s took a median of 276 days from receipt to decision, against 197 for FDA’s reviews in the same codes and years. Its devices cite 10 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, neurology panel, where it files most

How often FDA has decided Guangzhou Xinbo Electronic Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2017: 12018: 12020: 22021: 42023: 22024: 2
2017high 4 (2021) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Guangzhou Xinbo Electronic Co., Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Guangzhou Xinbo Electronic Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GXYElectrode, Cutaneous5decisions
  • NGXStimulator, Muscle, Powered, For Muscle Conditioning4decisions
  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter2decisions
  • GYBMedia, Electroconductive1decision

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 276 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 197 days; 3 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K163611Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd. · 20172cite it
  • K200402DR-HO'S Electro Therapy Conductive GelGuangzhou Xinbo Electronic Co., Ltd. · 20201cites it

What has FDA decided for it lately?

  • K230711Pain Therapy Device (Model: P.T.S-X)Guangzhou Xinbo Electronic Co., Ltd. · 2024
  • K231789Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)Guangzhou Xinbo Electronic Co., Ltd. · 2024
  • K231164Conductive carbon film electrodeGuangzhou Xinbo Electronic Co., Ltd. · 2023
  • K231167Conductive Silicone Rubber ElectrodeGuangzhou Xinbo Electronic Co., Ltd. · 2023
  • K202671DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)Guangzhou Xinbo Electronic Co., Ltd. · 2021
  • K212948Pain Therapy Device (Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)Guangzhou Xinbo Electronic Co., Ltd. · 2021
  • K202636Metallic Fabric ElectrodesGuangzhou Xinbo Electronic Co., Ltd. · 2021
  • K202638Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd. · 2021

All 12 as Guangzhou Xinbo Electronic Co., Ltd. →