510(k) Report

FDA applicant

Physio Systems, Inc.

Fremont, CA3 decisions1987–19910 recalls

FDA records 3 decisions for Physio Systems, Inc. (Fremont, CA) from 1987 to 1991: 3 510(k) clearances. Most are in product codes ISD (Exerciser, Measuring) and LXI (Guide, Drill, Ligament). 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 Physio Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Physio Systems, 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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Other applicant names beginning “Physio”

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