Power wheelchair (ZS-EW8026)
K-Number: K254206 · 2026-03-27
Decision Date2026-03-27
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Power wheelchair (ZS-EW8026) is a medical device manufactured by Ningbo Zhishan Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-27 under approval number K254206. 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 (ZS-EW8026)?
Power wheelchair (ZS-EW8026) is a medical device that received FDA 510(k) clearance on 2026-03-27. It is manufactured by Ningbo Zhishan Medical Technology Co., Ltd.. The 510(k) number is K254206.
When was Power wheelchair (ZS-EW8026) approved by the FDA?
Power wheelchair (ZS-EW8026) received FDA 510(k) clearance on 2026-03-27, under approval number K254206.
What company makes Power wheelchair (ZS-EW8026)?
Power wheelchair (ZS-EW8026) is manufactured by Ningbo Zhishan Medical Technology Co., Ltd..
What is the FDA product code for Power wheelchair (ZS-EW8026)?
The FDA product code for Power wheelchair (ZS-EW8026) 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.