Scooter, Model: R-100
K-Number: K182411 · 2019-06-24
Decision Date2019-06-24
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Scooter, Model: R-100 is a medical device manufactured by Yongkang Dingchang Industry & Trade Co., Ltd.. It received FDA 510(k) clearance on 2019-06-24 under approval number K182411. 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: R-100?
Scooter, Model: R-100 is a medical device that received FDA 510(k) clearance on 2019-06-24. It is manufactured by Yongkang Dingchang Industry & Trade Co., Ltd.. The 510(k) number is K182411.
When was Scooter, Model: R-100 approved by the FDA?
Scooter, Model: R-100 received FDA 510(k) clearance on 2019-06-24, under approval number K182411.
What company makes Scooter, Model: R-100?
Scooter, Model: R-100 is manufactured by Yongkang Dingchang Industry & Trade Co., Ltd..
What is the FDA product code for Scooter, Model: R-100?
The FDA product code for Scooter, Model: R-100 is INI.
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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.