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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. It received FDA 510(k) clearance on 2026-04-20 under 510(k) 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. The listed applicant is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. The 510(k) number is K253806.

When did Power Wheelchair (N5919 series) receive FDA 510(k) clearance?

Power Wheelchair (N5919 series) received FDA 510(k) clearance on 2026-04-20, under 510(k) number K253806.

Who is the listed applicant for Power Wheelchair (N5919 series)?

The FDA 510(k) record lists Zhejiang Innuovo Rehabilitation Devices Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Power Wheelchair (N5919 series)?

The FDA product code for Power Wheelchair (N5919 series) is ITI.

Other records listing Zhejiang Innuovo Rehabilitation Devices Co.,Ltd 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.

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Related Devices (Code: ITI)

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.

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.