510(k) Report

FDA applicant

Globalcare/Bay Medical Corp.

Holyoke, MA1 decision1991–19910 recalls

FDA records 1 decision for Globalcare/Bay Medical Corp. (Holyoke, MA) in 1991: 1 510(k) clearance. All are in product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). 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 Globalcare/Bay Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Globalcare/Bay Medical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Globalcare/Bay Medical Corp. 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 Relief1decision

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.

  • K913532TX 3 Tens ModifiedGlobalcare/Bay Medical Corp. · 19911cites it

What has FDA decided for it lately?

  • K913532TX 3 Tens ModifiedGlobalcare/Bay Medical Corp. · 1991

The one decision as Globalcare/Bay Medical Corp. →

Other applicant names beginning “Globalcare/Bay”

FDA records each applicant name separately; these may or may not be the same firm.

Globalcare Medical Technology Co., Ltd. 5Globalcare Intl., Inc. 4Globalcare 1