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510(k) K945175

MECHANICAL WHEELCHAIR 890.3850 by Lumex, Inc. — Product Code IOR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1995
Date Received
October 21, 1994
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 Lumex, Inc.

  • K963674 — LUMEX AIR (January 10, 1997)
  • K962123 — AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM (July 18, 1996)
  • K953675 — ALTADYNE (September 28, 1995)
  • K945257 — 577ES (ERGOSENSE) (April 26, 1995)
  • K944574 — LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI) (October 17, 1994)
  • K923977 — AKROTECH 4000 (February 12, 1993)
  • K895740 — SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART (February 22, 1990)

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)