CHILD'S WALKER— 510(k) K833869

Substantially Equivalent

Kaye Products, Inc.

FDA 510(k) clearance K833869 for CHILD'S WALKER, Substantially Equivalent on 1983-11-29. Applicant: Kaye Products, Inc..

Clearance details

Applicant
Kaye Products, Inc.
Product code
Code ITJ
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ITJ

product code ITJ
Death
8
Injury
571
Other
2
Total
581

Source: openFDA MAUDE database, through . 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.