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FDA 510(k)

Mobility Scooter, Model W3468

K-Number: K220207 · 2022-03-24

Decision Date2022-03-24
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Mobility Scooter, Model W3468 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 2022-03-24 under 510(k) number K220207. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mobility Scooter, Model W3468?

Mobility Scooter, Model W3468 is a medical device that received FDA 510(k) clearance on 2022-03-24. The listed applicant is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. The 510(k) number is K220207.

When did Mobility Scooter, Model W3468 receive FDA 510(k) clearance?

Mobility Scooter, Model W3468 received FDA 510(k) clearance on 2022-03-24, under 510(k) number K220207.

Who is the listed applicant for Mobility Scooter, Model W3468?

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 Mobility Scooter, Model W3468?

The FDA product code for Mobility Scooter, Model W3468 is INI.

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: INI)

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.