510(k) Report

FDA applicant

Boulder Impact Monitors, Inc.

Boulder, CO1 decision1988–19880 recalls

FDA records 1 decision for Boulder Impact Monitors, Inc. (Boulder, CO) in 1988: 1 510(k) clearance. All are in product code IRN (Device, Warning, Overload, External Limb…). 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, physical medicine panel, where it files most

How often FDA has decided Boulder Impact Monitors, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Boulder Impact Monitors, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Boulder Impact Monitors, 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?

  • IRNDevice, Warning, Overload, External Limb, Powered1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K882974Force Guard IBoulder Impact Monitors, Inc. · 19882cite it

What has FDA decided for it lately?

  • K882974Force Guard IBoulder Impact Monitors, Inc. · 1988

The one decision as Boulder Impact Monitors, Inc. →