PIVOT ASSIST— 510(k) K081053

Substantially Equivalent

Pivot Assist, LLC

FDA 510(k) clearance K081053 for PIVOT ASSIST, Substantially Equivalent on 2008-10-09. Applicant: Pivot Assist, LLC.

Clearance details

Applicant: Pivot Assist, LLC
Product code: Code INO
Advisory panel: Physical Medicine
Date received: 2008-04-14
Decision date: 2008-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garfield Hts., OH, US

Download summary PDF View on FDA.gov ↗

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.