CAPELLA— 510(k) K130788

Substantially Equivalent

Future Mobility Healthcare, Inc.

FDA 510(k) clearance K130788 for CAPELLA, Substantially Equivalent on 2013-12-05. Applicant: Future Mobility Healthcare, Inc..

Clearance details

Applicant: Future Mobility Healthcare, Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2013-03-22
Decision date: 2013-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

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.