FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000— 510(k) K863753

Substantially Equivalent

Foundations Plus, Inc.

FDA 510(k) clearance K863753 for FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000, Substantially Equivalent on 1986-10-30. Applicant: Foundations Plus, Inc..

Clearance details

Applicant: Foundations Plus, Inc.
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1986-09-25
Decision date: 1986-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colleyville, TX, US

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Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.