510(k) K023521— EASY LIFE

Substantially Equivalent

Berkline Corp.

Clearance details

Applicant: Berkline Corp.
Product code: Code INO
Advisory panel: Physical Medicine
Date received: 2002-10-21
Decision date: 2002-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morristown, TN, US

Adverse events under product code INO

product code INO

Death: 6
Total: 6

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.