FDA applicant

Shinsei Corp.

Walker, MI1 decision1981–19810 recalls

FDA records 1 decision for Shinsei Corp. (Walker, MI) in 1981: 1 510(k) clearance. All are in product code IMB (Cabinet, Moist Steam). 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 Shinsei Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shinsei Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Shinsei Corp.

Which product codes does it file in?

What has FDA decided for it lately?