510(k) K050674— PHYSIOGLOVE ES

Substantially Equivalent

Commwell , Ltd.

Clearance details

Applicant: Commwell , Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2005-03-15
Decision date: 2006-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.