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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 a medical device manufactured by Leggero, LLC. It received FDA 510(k) clearance on 2019-04-29 under approval 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. It is manufactured by Leggero, LLC. The 510(k) number is K182840.

When was Element Pediatric Wheelchair approved by the FDA?

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

What company makes Element Pediatric Wheelchair?

Element Pediatric Wheelchair is manufactured by Leggero, LLC.

What is the FDA product code for Element Pediatric Wheelchair?

The FDA product code for Element Pediatric Wheelchair is IOR.

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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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