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510(k) K260849

ICON 35; ICON 45; ICON 60; ICON 30FAF by Rehasense USA, Inc. — Product Code IOR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2026
Date Received
March 16, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Mechanical
Device Class
Class I
Regulation Number
890.3850
Review Panel
PM
Submission Type

A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and/or require an assistive device for mobility.

Other clearances for product code IOR

  • K260642 — Manual Wheelchair (LW01108) (June 2, 2026)
  • K260295 — Helio Kids; Apex P (May 28, 2026)
  • K254141 — Manual Wheelchair (DY01903(2)) (May 21, 2026)
  • K260121 — Manual Wheelchair (7101L, 7102LHD) (April 28, 2026)
  • K260319 — K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” wit (March 31, 2026)
  • K253632 — Manual Wheelchair (W50) (January 29, 2026)
  • K251886 — EmpowerRide NAVIGATOR (January 12, 2026)
  • K252825 — Manual Wheelchair (W45) (December 5, 2025)
  • K252828 — Manual Wheelchair (W47) (December 5, 2025)
  • K252687 — Manual Wheelchair (HM305-Air1, HM305-Air2) (November 21, 2025)