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FDA 510(k)

Mobility Scooter (Models: W3431D)

K-Number: K231428 · 2023-07-14

Decision Date2023-07-14
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Mobility Scooter (Models: W3431D) is a medical device manufactured by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. It received FDA 510(k) clearance on 2023-07-14 under approval number K231428. 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 (Models: W3431D)?

Mobility Scooter (Models: W3431D) is a medical device that received FDA 510(k) clearance on 2023-07-14. It is manufactured by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. The 510(k) number is K231428.

When was Mobility Scooter (Models: W3431D) approved by the FDA?

Mobility Scooter (Models: W3431D) received FDA 510(k) clearance on 2023-07-14, under approval number K231428.

What company makes Mobility Scooter (Models: W3431D)?

Mobility Scooter (Models: W3431D) is manufactured by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd.

What is the FDA product code for Mobility Scooter (Models: W3431D)?

The FDA product code for Mobility Scooter (Models: W3431D) is INI.

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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.