510(k) Report

FDA applicant

Home Wellness West

San Diego, CA2 decisions2000–20010 recalls

FDA records 2 decisions for Home Wellness West (San Diego, CA) from 2000 to 2001: 2 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and IPF (Stimulator, Muscle, Powered). 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 Home Wellness West’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Home Wellness West since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Home Wellness West 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
  • IPFStimulator, Muscle, Powered1decision

What has FDA decided for it lately?

  • K003258MS-One, Model MS-1Home Wellness West · 2001
  • K994065MS-One, Model MS-1Home Wellness West · 2000

All 2 as Home Wellness West →