Pure Tilt— 510(k) K152021

Substantially Equivalent

Proactive Comfort, LLC

FDA 510(k) clearance K152021 for Pure Tilt, Substantially Equivalent on 2016-03-31. Applicant: Proactive Comfort, LLC.

Clearance details

Applicant: Proactive Comfort, LLC
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2015-07-21
Decision date: 2016-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chantilly, VA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

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.