ICON 35; ICON 45; ICON 60; ICON 30FAF— 510(k) K260849

Substantially Equivalent

Rehasense USA, Inc.

FDA 510(k) clearance K260849 for ICON 35; ICON 45; ICON 60; ICON 30FAF, Substantially Equivalent on 2026-06-11. Applicant: Rehasense USA, Inc..

Clearance details

Applicant: Rehasense USA, Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2026-03-16
Decision date: 2026-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Romeoville, IL, 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.