PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1— 510(k) K083677

Substantially Equivalent

Commwell , Ltd.

FDA 510(k) clearance K083677 for PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1, Substantially Equivalent on 2009-03-10. Applicant: Commwell , Ltd..

Clearance details

Applicant: Commwell , Ltd.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 2008-12-11
Decision date: 2009-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.