510(k) Report

FDA applicant

Sport-Elec

Hampton, VA5 decisions2007–20100 recalls

FDA records 5 decisions for Sport-Elec (Hampton, VA) from 2007 to 2010: 5 510(k) clearances. All are in product code NGX (Stimulator, Muscle, Powered, For Muscle…). Its devices cite 10 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sport-Elec S.A.”.

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 Sport-Elec’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2007: 12008: 12009: 12010: 2
2007high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Sport-Elec”

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