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FDA 510(k)

Element Pediatric Wheelchair

K-Number: K182840 · 2019-04-29

ApplicantLeggero, LLC
Decision Date2019-04-29
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Element Pediatric Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Leggero, LLC. It received FDA 510(k) clearance on 2019-04-29 under 510(k) number K182840. 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 Element Pediatric Wheelchair?

Element Pediatric Wheelchair is a medical device that received FDA 510(k) clearance on 2019-04-29. The listed applicant is Leggero, LLC. The 510(k) number is K182840.

When did Element Pediatric Wheelchair receive FDA 510(k) clearance?

Element Pediatric Wheelchair received FDA 510(k) clearance on 2019-04-29, under 510(k) number K182840.

Who is the listed applicant for Element Pediatric Wheelchair?

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

What is the FDA product code for Element Pediatric Wheelchair?

The FDA product code for Element Pediatric Wheelchair is IOR.

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

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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