510(k) Report

FDA applicant

Nissin Medical Industries Co., Ltd.

Mosely, VA1 decision2005–20050 recalls

FDA records 1 decision for Nissin Medical Industries Co., Ltd. (Mosely, VA) in 2005: 1 510(k) clearance. All are in product code IOR (Wheelchair, Mechanical). Its devices cite 1 predicate, 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 Nissin Medical Industries Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nissin Medical Industries Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nissin Medical Industries Co., Ltd. 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?

  • IORWheelchair, Mechanical1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K052521Nissin Series Mechanical WheelchairNissin Medical Industries Co., Ltd. · 2005

The one decision as Nissin Medical Industries Co., Ltd. →

Other applicant names beginning “Nissin”

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

Nissin Medical, Inc. 1Nissin-Metec China Co., Ltd. 1