Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ICON 35; ICON 45; ICON 60; ICON 30FAF

K-Number: K260849 · 2026-06-11

ApplicantRehasense USA, Inc.
Decision Date2026-06-11
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ICON 35; ICON 45; ICON 60; ICON 30FAF is the device name listed in this FDA 510(k) record. The listed applicant is Rehasense USA, Inc.. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K260849. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICON 35; ICON 45; ICON 60; ICON 30FAF?

ICON 35; ICON 45; ICON 60; ICON 30FAF is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Rehasense USA, Inc.. The 510(k) number is K260849.

When did ICON 35; ICON 45; ICON 60; ICON 30FAF receive FDA 510(k) clearance?

ICON 35; ICON 45; ICON 60; ICON 30FAF received FDA 510(k) clearance on 2026-06-11, under 510(k) number K260849.

Who is the listed applicant for ICON 35; ICON 45; ICON 60; ICON 30FAF?

The FDA 510(k) record lists Rehasense USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICON 35; ICON 45; ICON 60; ICON 30FAF?

The FDA product code for ICON 35; ICON 45; ICON 60; ICON 30FAF is IOR.

Related Devices (Code: IOR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K252370GEN 4 JOY WheelchairFree Wheelchair MissionK261076Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.K261075Manual Wheelchair (MS01);Manual Wheelchair (MA01)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.K260642Manual Wheelchair (LW01108)Anhui Longway Medical Technology Co., Ltd.K260295Helio Kids; Apex PMotion Composites

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑