Power Wheelchair (W5538)
K-Number: K242471 · 2024-11-18
Decision Date2024-11-18
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Power Wheelchair (W5538) is a medical device manufactured by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. It received FDA 510(k) clearance on 2024-11-18 under approval number K242471. 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 (W5538)?
Power Wheelchair (W5538) is a medical device that received FDA 510(k) clearance on 2024-11-18. It is manufactured by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. The 510(k) number is K242471.
When was Power Wheelchair (W5538) approved by the FDA?
Power Wheelchair (W5538) received FDA 510(k) clearance on 2024-11-18, under approval number K242471.
What company makes Power Wheelchair (W5538)?
Power Wheelchair (W5538) is manufactured by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd.
What is the FDA product code for Power Wheelchair (W5538)?
The FDA product code for Power Wheelchair (W5538) 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.