510(k) K111739

KIDS ROCK 3 CHAIR by Pride Mobility Products Corp. — Product Code IOR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 12, 2011
Date Received: June 21, 2011
Clearance Type: Special
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 Pride Mobility Products Corp.

K091578 — LIFT CHAIR, MODEL T3 (December 2, 2009)
K092961 — JAZZY FRONTIE (October 23, 2009)
K092088 — VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713 (July 16, 2009)
K091113 — MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL (May 11, 2009)
K090805 — V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS (April 3, 2009)
K090524 — GO GO ELITE TRAVELER V THREE WHEEL SCOOTER, MODEL SC40EV (March 19, 2009)
K072165 — VICTORY THREE WHEEL SCOOTER, MODEL: SC610 (August 17, 2007)
K071949 — VICTORY, 4 WHEEL SCOOTER / MODEL, # SC1740 (August 1, 2007)
K070950 — LIFT CHAIR, MODEL C5 (April 16, 2007)
K063389 — GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54 (November 17, 2006)

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)