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FDA 510(k)

Helio Kids; Apex P

K-Number: K260295 · 2026-05-28

ApplicantMotion Composites
Decision Date2026-05-28
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Helio Kids; Apex P is the device name listed in this FDA 510(k) record. The listed applicant is Motion Composites. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K260295. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Helio Kids; Apex P?

Helio Kids; Apex P is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Motion Composites. The 510(k) number is K260295.

When did Helio Kids; Apex P receive FDA 510(k) clearance?

Helio Kids; Apex P received FDA 510(k) clearance on 2026-05-28, under 510(k) number K260295.

Who is the listed applicant for Helio Kids; Apex P?

The FDA 510(k) record lists Motion Composites as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Helio Kids; Apex P?

The FDA product code for Helio Kids; Apex P is IOR.

Other records listing Motion Composites as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K161425APEX Manual Wheelchair

Related Devices (Code: IOR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K252370GEN 4 JOY WheelchairFree Wheelchair MissionK261076Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.K261075Manual Wheelchair (MS01);Manual Wheelchair (MA01)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.K260849ICON 35; ICON 45; ICON 60; ICON 30FAFRehasense USA, Inc.K260642Manual Wheelchair (LW01108)Anhui Longway Medical Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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