FDA applicant

Stealth Products

Cleveland, OH1 decision2005–20050 recalls

FDA records 1 decision for Stealth Products (Cleveland, OH) in 2005: 1 510(k) clearance. All are in product code ITI (Wheelchair, Powered). 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 Stealth Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stealth Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Stealth Products’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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Other applicant names beginning “Stealth”

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

Stealth Therapeutics, Incorporated 2

Stealth Products

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Stealth”