Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL

FDA 510(k) K200583 · Ki Mobility, LLC

Substantially Equivalent

510(k) numberK200583

Submission

Device name
Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL
Applicant
Ki Mobility, LLC
Stevens Point, WI, US
Received
March 6, 2020
Decision date
September 5, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IOR – Wheelchair, Mechanical
Device class
Class I (low risk)
Regulation
21 CFR 890.3850
Specialty
Physical Medicine

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 510(k)s with product code IOR

510(k)DeviceApplicantDecision
K261571Manual Wheelchair (H008, PCK7)IOR · Traditional Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.08/06/2026SE
K252370GEN 4 JOY WheelchairIOR · Traditional Free Wheelchair Mission07/24/2026SE
K261076Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)IOR · Traditional GuangDong Yong Yi Rehabilitation Equipment…06/22/2026SE
K261075Manual Wheelchair (MS01);Manual Wheelchair (MA01)IOR · Traditional GuangDong Yong Yi Rehabilitation Equipment…06/22/2026SE
K260849Icon 35; Icon 45; Icon 60; Icon 30FAFIOR · Traditional Rehasense USA, Inc.06/11/2026SE
K260642Manual Wheelchair (LW01108)IOR · Traditional Anhui Longway Medical Technology Co., Ltd.06/02/2026SE
K260295Helio Kids; Apex PIOR · Traditional Motion Composites05/28/2026SE
K254141Manual Wheelchair (DY01903(2))IOR · Traditional Guangdong Dayang Medical Technology Co., Ltd.05/21/2026SE
K260121Manual Wheelchair (7101L, 7102LHD)IOR · Traditional Foshan Nanhai Hongchen Medical Equipment Co., Ltd.04/28/2026SE
K260319K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with…IOR · Traditional Zhenjiang Assure Medical Equipment Co., Ltd.03/31/2026SE

More from Zhenjiang Assure Medical Equipment Co., Ltd.

510(k)DeviceDecision
K201869Ki Power Tilt SystemITI · Traditional 09/05/2023SE
K223533Little Wave Arc; Little Wave FlipLBE · Traditional 08/31/2023SE
K223527Little Wave Clik, Rogue XP, Little Wave XP, SparkIOR · Traditional 08/31/2023SE
K062660CatalysyIOR · Traditional 10/24/2006SE

Questions and answers

When was Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL cleared by the FDA?

Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL (K200583) received a 510(k) decision of Substantially Equivalent on September 5, 2023, 1,278 days after the submission was received.

What is the product code of K200583?

The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.