510(k) Report

FDA applicant

Self Regulation Systems, Inc.

Redmond, WA3 decisions1984–19880 recalls

FDA records 3 decisions for Self Regulation Systems, Inc. (Redmond, WA) from 1984 to 1988: 3 510(k) clearances. All are in product code HCC (Device, Biofeedback). 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 Self Regulation Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Self Regulation Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Self Regulation 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?

  • HCCDevice, Biofeedback3decisions

What has FDA decided for it lately?

  • K875308Professional Series Biofeedback Devices Model 421Self Regulation Systems, Inc. · 1988
  • K870793Self Regulation Sys Prof Series Biofeedback DeviceSelf Regulation Systems, Inc. · 1987
  • K840223Orion Biofeedback Data AcquisitionSelf Regulation Systems, Inc. · 1984

All 3 as Self Regulation Systems, Inc. →

Other applicant names beginning “Self”

FDA records each applicant name separately; these may or may not be the same firm.

Self Care Systems, Inc. 3Self Doctor Care, LLC 1Self Sharpening Surgical Steel, Inc. 1