510(k) Report

FDA applicant

Tone World International

Pelham, NY1 decision1994–19940 recalls

FDA records 1 decision for Tone World International (Pelham, NY) in 1994: 1 510(k) clearance. All are in product code IOR (Wheelchair, Mechanical). 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 Tone World International’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tone World International since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Tone”

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