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510(k) K171017

Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T by Convaid Products, LLC — Product Code IOR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2017
Date Received
April 5, 2017
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 by Convaid Products, LLC

  • K140416 — TREKKER, TREKKER TRANSIT (September 17, 2014)
  • K120501 — CHAMP CHAMP TRANSIT (September 20, 2012)
  • K032402 — RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T, (September 24, 2003)
  • K840250 — CARRIER (February 9, 1984)
  • K833195 — UMBRELLA WALKER (October 27, 1983)
  • K822992 — PEOPLE MOVER (October 27, 1982)
  • K810676 — CONVAID CRUISER CP4M (March 26, 1981)
  • K781947 — STROLLER, THERAPY (December 4, 1978)

Other clearances for product code IOR

  • K253632 — Manual Wheelchair (W50) (January 29, 2026)
  • K251886 — EmpowerRide NAVIGATOR (January 12, 2026)
  • K252828 — Manual Wheelchair (W47) (December 5, 2025)
  • K252825 — Manual Wheelchair (W45) (December 5, 2025)
  • K252687 — Manual Wheelchair (HM305-Air1, HM305-Air2) (November 21, 2025)
  • K250576 — Flexx Junior (FLX-J00, FLX-J50) (November 4, 2025)
  • K252517 — Manual Wheelchair (SYIV100A008) (October 3, 2025)
  • K241374 — Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) (February 28, 2025)
  • K243111 — Bowhead ERA Wheelchairs (January 10, 2025)
  • K242722 — Manual Wheelchair (MASY23) (November 22, 2024)