DIGNITY 100— 510(k) K082246

Substantially Equivalent

Dignity Medical Devices, Inc.

FDA 510(k) clearance K082246 for DIGNITY 100, Substantially Equivalent on 2008-09-09. Applicant: Dignity Medical Devices, Inc..

Clearance details

Applicant: Dignity Medical Devices, Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2008-08-08
Decision date: 2008-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, 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.