510(k) Report

FDA applicant

Psi Health Solutions, Inc.

Pacific Grove, CA1 decision2007–20071 recall

FDA records 1 decision for Psi Health Solutions, Inc. (Pacific Grove, CA) in 2007: 1 510(k) clearance. All are in product code MVV (Device, Acupressure). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Psi Health Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Psi Health Solutions, Inc. 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?

  • MVVDevice, Acupressure1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K070766Psi BandsPsi Health Solutions, Inc. · 20071cites it

What has FDA decided for it lately?

  • K070766Psi BandsPsi Health Solutions, Inc. · 20071 recall

The one decision as Psi Health Solutions, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K070766Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black…Apr 26, 2007