FDA applicant
Sport-Elec
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
How often FDA has decided Sport-Elec’s devices, and how often a recall has named them.
FDA decisions per year
2in 2010
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Sport-Elec’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Sport-Elec”
FDA records each applicant name separately; these may or may not be the same firm.