510(k) Report

FDA applicant

Hanuri Distribution, Inc.

Chatsworth, CA2 decisions2011–20200 recalls

FDA records 2 decisions for Hanuri Distribution, Inc. (Chatsworth, CA) from 2011 to 2020: 2 510(k) clearances. Most are in product codes IRP (Massager, Powered Inflatable Tube) and JOW (Sleeve, Limb, Compressible). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Hanuri Distribution, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2011: 12020: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Hanuri Distribution, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hanuri Distribution, 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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