510(k) Report

FDA applicant

Richway Intl., Inc.

Honolulu, HI1 decision2008–20080 recalls

FDA records 1 decision for Richway Intl., Inc. (Honolulu, HI) in 2008: 1 510(k) clearance. All are in product code IRT (Pad, Heating, Powered). 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 Richway Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Richway Intl., Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IRTPad, Heating, 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.

  • K072534Bio-Mat 2000Richway Intl., Inc. · 20082cite it

What has FDA decided for it lately?

  • K072534Bio-Mat 2000Richway Intl., Inc. · 2008

The one decision as Richway Intl., Inc. →