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510(k) K941157

BASIC RECLINE CHAIR by Labac Systems, Inc. — Product Code IOR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1994
Date Received
March 11, 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 Labac Systems, Inc.

  • K934418 — BASIC TILT CHAIR ( BTC ) (January 7, 1994)
  • K932639 — MANUAL TILT RECLINE CHAIR (MTC) (July 22, 1993)
  • K923362 — REDUCED SHEAR OWR RECLINE SYSTEM (March 26, 1993)
  • K921028 — MANUAL RECLINING CHAIR (March 24, 1993)
  • K923363 — ADJUSTABLE SLIDING BACK POWER RECLINE SYSTEM (March 24, 1993)
  • K923364 — TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST (March 22, 1993)
  • K925272 — PEDIATRIC TILT CHAIR (February 12, 1993)
  • K923366 — TILT SEATING SYSTEM (February 12, 1993)
  • K921136 — MANUAL TILT CHAIR (April 2, 1992)
  • K921027 — MANUAL CHAIR BASE (March 20, 1992)

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)