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510(k) K111739

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

K111739 is an FDA 510(k) premarket notification submitted by Pride Mobility Products Corp. for the device "KIDS ROCK 3 CHAIR". The FDA issued a decision of Substantially Equivalent on August 12, 2011. The device falls under product code IOR (Wheelchair, Mechanical), a Class I device regulated under 21 CFR 890.3850. Pride Mobility Products Corp. has at least 10 other 510(k) clearances on record.

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

  • K261076 — Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) (June 22, 2026)
  • K261075 — Manual Wheelchair (MS01);Manual Wheelchair (MA01) (June 22, 2026)
  • K260849 — ICON 35; ICON 45; ICON 60; ICON 30FAF (June 11, 2026)
  • K260642 — Manual Wheelchair (LW01108) (June 2, 2026)
  • K260295 — Helio Kids; Apex P (May 28, 2026)
  • K254141 — Manual Wheelchair (DY01903(2)) (May 21, 2026)
  • K260121 — Manual Wheelchair (7101L, 7102LHD) (April 28, 2026)
  • K260319 — K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” wit (March 31, 2026)
  • K253632 — Manual Wheelchair (W50) (January 29, 2026)
  • K251886 — EmpowerRide NAVIGATOR (January 12, 2026)

FDA data resources