510(k) Report

FDA applicant

Health Ent., Inc.

North Attleboro, MA1 decision2004–20040 recalls

FDA records 1 decision for Health Ent., Inc. (North Attleboro, MA) in 2004: 1 510(k) clearance. All are in product code MVV (Device, Acupressure). Its devices cite 1 predicate, 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

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

FDA decisions per year

No FDA decision for Health Ent., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Health Ent., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Health Ent., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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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 4 times; 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.

  • K041877Acu-Strap Motion Sickness BandHealth Ent., Inc. · 20044cite it

What has FDA decided for it lately?

  • K041877Acu-Strap Motion Sickness BandHealth Ent., Inc. · 2004

The one decision as Health Ent., Inc. →