510(k) Report

FDA applicant

Biobands Distributors, Inc.

Washington, DC1 decision2005–20050 recalls

FDA records 1 decision for Biobands Distributors, Inc. (Washington, DC) in 2005: 1 510(k) clearance. All are in product code MVV (Device, Acupressure). Its devices cite 2 predicates, 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 Biobands Distributors, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biobands Distributors, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biobands Distributors, 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 2 predicates; 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.

  • K051397BiobandsBiobands Distributors, Inc. · 20051cites it

What has FDA decided for it lately?

  • K051397BiobandsBiobands Distributors, Inc. · 2005

The one decision as Biobands Distributors, Inc. →