510(k) Report

FDA applicant

Us Bionics, Inc. (Dba Suitx)

Emeryville, CA1 decision2019–20190 recalls

FDA records 1 decision for Us Bionics, Inc. (Dba Suitx) (Emeryville, CA) in 2019: 1 510(k) clearance. All are in product code PHL (Powered Exoskeleton). 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 Us Bionics, Inc. (Dba Suitx)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Us Bionics, Inc. (Dba Suitx) by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PHLPowered Exoskeleton1decision

What has FDA decided for it lately?

  • K183152PhoenixUs Bionics, Inc. (Dba Suitx) · 2019

The one decision as Us Bionics, Inc. (Dba Suitx) →