DeviceClearance

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.. Device class: 1.

Summary

Rehasense USA's clearance covers four ICON models: ICON 35, ICON 45, ICON 60, and ICON 30FAF. They're filed under IOR, mechanical wheelchairs, and the record doesn't say how the models differ.

Class I, 21 CFR 890.3850. Physical Medicine is both the classification panel and the review panel. It was a Traditional 510(k).

Rehasense filed from Romeoville, Illinois. Review took 87 calendar days (March 16 to June 11, 2026).

Clearance details

Applicant
Rehasense USA, Inc.
Product code
Product code IOR
Device class
Class 1
Regulation
21 CFR 890.3850
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Romeoville, IL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code IOR

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Adverse events under product code IOR

product code IOR
Death
10
Injury
232
Other
2
Total
244

Source: openFDA MAUDE database, through . 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.