SANDBOX I, SANDBOX II, SANDBOX JR.— 510(k) K903321

Substantially Equivalent

Sandbox Ent.

FDA 510(k) clearance K903321 for SANDBOX I, SANDBOX II, SANDBOX JR., Substantially Equivalent on 1991-02-19. Applicant: Sandbox Ent..

Clearance details

Applicant: Sandbox Ent.
Product code: Code IRT
Advisory panel: Physical Medicine
Date received: 1990-07-25
Decision date: 1991-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt. Gilead, OH, US

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Adverse events under product code IRT

product code IRT

Injury: 668
Total: 668

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.