K260849
- 510(k) number
- K260849
- Device name
- ICON 35; ICON 45; ICON 60; ICON 30FAF
- Applicant
- Rehasense USA, Inc. IL · US
- Product code
- IOR — Wheelchair, Mechanical
- Decision date
- 2026-06-11
- Date received
- 2026-03-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K260849
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.