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FDA 510(k)

APEX Manual Wheelchair

K-Number: K161425 · 2016-12-05

ApplicantMotion Composites
Decision Date2016-12-05
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

APEX Manual Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Motion Composites. It received FDA 510(k) clearance on 2016-12-05 under 510(k) number K161425. 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 APEX Manual Wheelchair?

APEX Manual Wheelchair is a medical device that received FDA 510(k) clearance on 2016-12-05. The listed applicant is Motion Composites. The 510(k) number is K161425.

When did APEX Manual Wheelchair receive FDA 510(k) clearance?

APEX Manual Wheelchair received FDA 510(k) clearance on 2016-12-05, under 510(k) number K161425.

Who is the listed applicant for APEX Manual Wheelchair?

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 APEX Manual Wheelchair?

The FDA product code for APEX Manual Wheelchair 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.

K260295Helio Kids; Apex P

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.

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.K260295Helio Kids; Apex PMotion Composites

Official Source

View on FDA Database →

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

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