FDA 510(k)

Merits P335 Powered Wheelchair

K-Number: K220529 · 2022-03-18

ApplicantMerits Health Products Co., Ltd.

Decision Date2022-03-18

Product CodeITI

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Merits P335 Powered Wheelchair is a medical device manufactured by Merits Health Products Co., Ltd.. It received FDA 510(k) clearance on 2022-03-18 under approval number K220529. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Merits P335 Powered Wheelchair?

Merits P335 Powered Wheelchair is a medical device that received FDA 510(k) clearance on 2022-03-18. It is manufactured by Merits Health Products Co., Ltd.. The 510(k) number is K220529.

When was Merits P335 Powered Wheelchair approved by the FDA?

Merits P335 Powered Wheelchair received FDA 510(k) clearance on 2022-03-18, under approval number K220529.

What company makes Merits P335 Powered Wheelchair?

Merits P335 Powered Wheelchair is manufactured by Merits Health Products Co., Ltd..

What is the FDA product code for Merits P335 Powered Wheelchair?

The FDA product code for Merits P335 Powered Wheelchair is ITI.

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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.