Scooter (Model: FDB01)
K-Number: K201196 · 2021-06-25
Decision Date2021-06-25
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Scooter (Model: FDB01) is a medical device manufactured by Nanjing Jin Bai HE Medical Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2021-06-25 under approval number K201196. 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 Scooter (Model: FDB01)?
Scooter (Model: FDB01) is a medical device that received FDA 510(k) clearance on 2021-06-25. It is manufactured by Nanjing Jin Bai HE Medical Apparatus Co., Ltd.. The 510(k) number is K201196.
When was Scooter (Model: FDB01) approved by the FDA?
Scooter (Model: FDB01) received FDA 510(k) clearance on 2021-06-25, under approval number K201196.
What company makes Scooter (Model: FDB01)?
Scooter (Model: FDB01) is manufactured by Nanjing Jin Bai HE Medical Apparatus Co., Ltd..
What is the FDA product code for Scooter (Model: FDB01)?
The FDA product code for Scooter (Model: FDB01) is INI.
Other Devices by Nanjing Jin Bai HE Medical Apparatus 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.