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510(k) K260295

Device
Helio Kids; Apex P
Applicant
Motion Composites
510(k) number
K260295
Product code
IOR
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-28
Date received
2026-01-29
Regulation
890.3850
Classification name
Wheelchair, Mechanical
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Catherine Marquis
Address
160 Armand-Majeau Sud Saint-Roch-Del’Achigan CA JOK 3H0 JOK 3H0

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IOR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261075Manual Wheelchair (MS01);Manual Wheelchair (MA01)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.2026-06-22
K261076Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.2026-06-22
K260849ICON 35; ICON 45; ICON 60; ICON 30FAFRehasense USA, Inc.2026-06-11
K260642Manual Wheelchair (LW01108)Anhui Longway Medical Technology Co., Ltd.2026-06-02
K254141Manual Wheelchair (DY01903(2))Guangdong Dayang Medical Technology Co., Ltd.2026-05-21
K260121Manual Wheelchair (7101L, 7102LHD)Foshan Nanhai Hongchen Medical Equipment Co., Ltd.2026-04-28
K260319K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR))Zhenjiang Assure Medical Equipment Co., Ltd.2026-03-31
K253632Manual Wheelchair (W50)Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.2026-01-29
K251886EmpowerRide NAVIGATOREmpower Ride, LLC2026-01-12
K252825Manual Wheelchair (W45)Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.2025-12-05
K252828Manual Wheelchair (W47)Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.2025-12-05
K252687Manual Wheelchair (HM305-Air1, HM305-Air2)Suzhou Master Machinery Manufacturing Co.,Ltd2025-11-21
K250576Flexx Junior (FLX-J00, FLX-J50)Karma Mobility Co, Ltd.2025-11-04
K252517Manual Wheelchair (SYIV100A008)Ningbo Shenyu Medical Equipment Co.,Ltd2025-10-03
K241374Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)Anhui Jbh Medical Apparatus Co., Ltd.2025-02-28