KAYE SCOOT-ABOUT, MODEL SB1— 510(k) K924848

Substantially Equivalent

Kaye Products, Inc.

FDA 510(k) clearance K924848 for KAYE SCOOT-ABOUT, MODEL SB1, Substantially Equivalent on 1993-02-12. Applicant: Kaye Products, Inc..

Clearance details

Applicant: Kaye Products, Inc.
Product code: Code INM
Advisory panel: Physical Medicine
Date received: 1992-09-28
Decision date: 1993-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hillsborough, NC, US

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Adverse events under product code INM

product code INM

Death: 3
Total: 3

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.