510(k) Report

FDA applicant

Shian Jia Meei Enterprise Co., Ltd.

Flagstaff, AZ2 decisions2004–20050 recalls

FDA records 2 decisions for Shian Jia Meei Enterprise Co., Ltd. (Flagstaff, AZ) from 2004 to 2005: 2 510(k) clearances. All are in product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). Its devices cite 2 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 Shian Jia Meei Enterprise Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shian Jia Meei Enterprise Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shian Jia Meei Enterprise Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K052182Shian Jia Meei Two Channel Digital T.E.N.S.Shian Jia Meei Enterprise Co., Ltd. · 20051cites it

What has FDA decided for it lately?

  • K052182Shian Jia Meei Two Channel Digital T.E.N.S.Shian Jia Meei Enterprise Co., Ltd. · 2005
  • K040311Shian Jia Meei Digatal PWN Tens, Model YW-6000/UC-332/UC-330/ST-331Shian Jia Meei Enterprise Co., Ltd. · 2004

All 2 as Shian Jia Meei Enterprise Co., Ltd. →