510(k) K231032— AMP by Method Mobility, AMP Plus (or +) by Method Mobility

Substantially Equivalent

Method Mobility

Clearance details

Applicant: Method Mobility
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2023-04-11
Decision date: 2023-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fresno, CA, US

Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

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.