Power wheelchair (Model:BC-EA8000)
K-Number: K232121 · 2023-09-15
Decision Date2023-09-15
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Power wheelchair (Model:BC-EA8000) is a medical device manufactured by Ningbo Baichen Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2023-09-15 under approval number K232121. 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 (Model:BC-EA8000)?
Power wheelchair (Model:BC-EA8000) is a medical device that received FDA 510(k) clearance on 2023-09-15. It is manufactured by Ningbo Baichen Medical Devices Co., Ltd.. The 510(k) number is K232121.
When was Power wheelchair (Model:BC-EA8000) approved by the FDA?
Power wheelchair (Model:BC-EA8000) received FDA 510(k) clearance on 2023-09-15, under approval number K232121.
What company makes Power wheelchair (Model:BC-EA8000)?
Power wheelchair (Model:BC-EA8000) is manufactured by Ningbo Baichen Medical Devices Co., Ltd..
What is the FDA product code for Power wheelchair (Model:BC-EA8000)?
The FDA product code for Power wheelchair (Model:BC-EA8000) is ITI.
Related Clinical Trials
Other Devices by Ningbo Baichen Medical Devices Co., Ltd.
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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.