Mobility Scooter (S3)
K-Number: K253643 · 2026-02-18
Decision Date2026-02-18
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Mobility Scooter (S3) is a medical device manufactured by Shenzhen Zhimahuaerkai Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-02-18 under approval number K253643. 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 Mobility Scooter (S3)?
Mobility Scooter (S3) is a medical device that received FDA 510(k) clearance on 2026-02-18. It is manufactured by Shenzhen Zhimahuaerkai Technology Co., Ltd.. The 510(k) number is K253643.
When was Mobility Scooter (S3) approved by the FDA?
Mobility Scooter (S3) received FDA 510(k) clearance on 2026-02-18, under approval number K253643.
What company makes Mobility Scooter (S3)?
Mobility Scooter (S3) is manufactured by Shenzhen Zhimahuaerkai Technology Co., Ltd..
What is the FDA product code for Mobility Scooter (S3)?
The FDA product code for Mobility Scooter (S3) is INI.
Other Devices by Shenzhen Zhimahuaerkai Technology 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.