510(k) K870295

SIOUX MODEL 102ALW WHEELCHAIR by Redman, Inc. — Product Code IOR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 10, 1987
Date Received: January 28, 1987
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 Redman, Inc.

K940851 — RED PACK MANLUAL POWER WHEELCHAIR CONVERSION KIT (February 3, 1995)
K935751 — GERONIMO PR (February 3, 1995)
K940920 — ROAD SAVAGE (February 3, 1995)
K940919 — CHIEF SR (February 3, 1995)
K935750 — GERONIMO (February 3, 1995)
K940852 — CHIEF STANDUP WHEELCHAIR (February 3, 1995)
K935749 — ROAD WARRIOR (January 13, 1995)
K870298 — REDMAN ACCESSORIES (February 26, 1987)
K870292 — CHEYENNE MODEL 107A WHEELCHAIR (February 10, 1987)
K870293 — NAVAJO MODEL 103A WHEELCHAIR (February 10, 1987)

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)