510(k) Report

FDA applicant

S.H.P. Intl. Pty., Ltd.

Eugene, OR2 decisions1996–20020 recalls

FDA records 2 decisions for S.H.P. Intl. Pty., Ltd. (Eugene, OR) from 1996 to 2002: 2 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and BWK (Stimulator, Electro-Acupuncture). Its devices cite 1 predicate, 1 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 S.H.P. Intl. Pty., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for S.H.P. Intl. Pty., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — S.H.P. Intl. Pty., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like S.H.P. Intl. Pty., 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?

  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision
  • BWKStimulator, Electro-Acupuncture1decision

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K014273AcustimS.H.P. Intl. Pty., Ltd. · 20022cite it
  • K954334AcuplusS.H.P. Intl. Pty., Ltd. · 19961cites it

What has FDA decided for it lately?

  • K014273AcustimS.H.P. Intl. Pty., Ltd. · 2002
  • K954334AcuplusS.H.P. Intl. Pty., Ltd. · 1996

All 2 as S.H.P. Intl. Pty., Ltd. →