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510(k) K935749

ROAD WARRIOR by Redman, Inc. — Product Code ITI

K935749 is an FDA 510(k) premarket notification submitted by Redman, Inc. for the device "ROAD WARRIOR". The FDA issued a decision of SN on January 13, 1995. The device falls under product code ITI (Wheelchair, Powered), a Class II device regulated under 21 CFR 890.3860. Redman, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
January 13, 1995
Date Received
November 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Powered
Device Class
Class II
Regulation Number
890.3860
Review Panel
PM
Submission Type

A powered wheelchair is a battery-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 require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).

Other clearances by Redman, Inc.

  • K940919 — CHIEF SR (February 3, 1995)
  • K935750 — GERONIMO (February 3, 1995)
  • K940852 — CHIEF STANDUP WHEELCHAIR (February 3, 1995)
  • K940851 — RED PACK MANLUAL POWER WHEELCHAIR CONVERSION KIT (February 3, 1995)
  • K935751 — GERONIMO PR (February 3, 1995)
  • K940920 — ROAD SAVAGE (February 3, 1995)
  • K870298 — REDMAN ACCESSORIES (February 26, 1987)
  • K870295 — SIOUX MODEL 102ALW WHEELCHAIR (February 10, 1987)
  • K870293 — NAVAJO MODEL 103A WHEELCHAIR (February 10, 1987)
  • K870291 — CHEROKEE MODEL 102A WHEELCHAIR (February 10, 1987)

Other clearances for product code ITI

  • K261149 — Electric Wheelchair (DY611A-2, DY612A-1) (July 10, 2026)
  • K261396 — Electric Wheelchair (July 8, 2026)
  • K261164 — Electric wheelchair (XW-LY007 ) (July 7, 2026)
  • K260937 — Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) (June 24, 2026)
  • K253812 — Power Wheelchair (W5915B, W5915C, W5915D) (June 18, 2026)
  • K260335 — Electric Wheelchair (S500-6) (June 15, 2026)
  • K261175 — WHILL (WHILL Model C2) (June 12, 2026)
  • K260056 — Power Wheelchair (N5515A, N5516, N5517A, N5519) (June 5, 2026)
  • K260373 — Electric Wheelchair (DF506) (June 3, 2026)
  • K253241 — Electric Wheelchair (Y207BL) (May 13, 2026)

FDA data resources