Power Wheelchair (N5919 series)
K-Number: K253806 · 2026-04-20
Decision Date2026-04-20
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Power Wheelchair (N5919 series) is a medical device manufactured by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. It received FDA 510(k) clearance on 2026-04-20 under approval number K253806. 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 Power Wheelchair (N5919 series)?
Power Wheelchair (N5919 series) is a medical device that received FDA 510(k) clearance on 2026-04-20. It is manufactured by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. The 510(k) number is K253806.
When was Power Wheelchair (N5919 series) approved by the FDA?
Power Wheelchair (N5919 series) received FDA 510(k) clearance on 2026-04-20, under approval number K253806.
What company makes Power Wheelchair (N5919 series)?
Power Wheelchair (N5919 series) is manufactured by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd.
What is the FDA product code for Power Wheelchair (N5919 series)?
The FDA product code for Power Wheelchair (N5919 series) is ITI.
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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.