Aingeal Activity System— 510(k) K153275

Substantially Equivalent

Intelesens, Ltd.

FDA 510(k) clearance K153275 for Aingeal Activity System, Substantially Equivalent on 2016-02-26. Applicant: Intelesens, Ltd..

Clearance details

Applicant: Intelesens, Ltd.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2015-11-12
Decision date: 2016-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belfast, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.