SPLASH & GO II— 510(k) K955295

Substantially Equivalent

Kid'S Wheel-Chairs

FDA 510(k) clearance K955295 for SPLASH & GO II, Substantially Equivalent on 1995-11-30. Applicant: Kid'S Wheel-Chairs.

Clearance details

Applicant: Kid'S Wheel-Chairs
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1995-11-16
Decision date: 1995-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kenneth City, FL, US

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Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.