510(k) Report

FDA applicant

Flexable Systems, Inc.

Fountain Hills, AZ1 decision2001–20010 recalls

FDA records 1 decision for Flexable Systems, Inc. (Fountain Hills, AZ) in 2001: 1 510(k) clearance. All are in product code GYD (Transducer, Tremor). 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 Flexable Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Flexable Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Flexable Systems, 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?

  • GYDTransducer, Tremor1decision

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.

  • K010270TremorometerFlexable Systems, Inc. · 20011cites it

What has FDA decided for it lately?

  • K010270TremorometerFlexable Systems, Inc. · 2001

The one decision as Flexable Systems, Inc. →