Electric Wheelchair (GY-E001)
K-Number: K251891 · 2025-09-09
Decision Date2025-09-09
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Electric Wheelchair (GY-E001) is a medical device manufactured by Shandong Guyue Healthcare Appliance Co., Ltd.. It received FDA 510(k) clearance on 2025-09-09 under approval number K251891. 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 Electric Wheelchair (GY-E001)?
Electric Wheelchair (GY-E001) is a medical device that received FDA 510(k) clearance on 2025-09-09. It is manufactured by Shandong Guyue Healthcare Appliance Co., Ltd.. The 510(k) number is K251891.
When was Electric Wheelchair (GY-E001) approved by the FDA?
Electric Wheelchair (GY-E001) received FDA 510(k) clearance on 2025-09-09, under approval number K251891.
What company makes Electric Wheelchair (GY-E001)?
Electric Wheelchair (GY-E001) is manufactured by Shandong Guyue Healthcare Appliance Co., Ltd..
What is the FDA product code for Electric Wheelchair (GY-E001)?
The FDA product code for Electric Wheelchair (GY-E001) 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.