ELD-ARONDAK CHAIR— 510(k) K926053

Substantially Equivalent

Alert Care, Inc.

FDA 510(k) clearance K926053 for ELD-ARONDAK CHAIR, Substantially Equivalent on 1993-03-22. Applicant: Alert Care, Inc..

Clearance details

Applicant: Alert Care, Inc.
Product code: Code INM
Advisory panel: Physical Medicine
Date received: 1992-12-01
Decision date: 1993-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Borden, IN, 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.