Decision Date2021-08-25
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Elvie Stride is a medical device manufactured by Chiaro Technology Limited. It received FDA 510(k) clearance on 2021-08-25 under approval number K210936. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Elvie Stride?
Elvie Stride is a medical device that received FDA 510(k) clearance on 2021-08-25. It is manufactured by Chiaro Technology Limited. The 510(k) number is K210936.
When was Elvie Stride approved by the FDA?
Elvie Stride received FDA 510(k) clearance on 2021-08-25, under approval number K210936.
What company makes Elvie Stride?
Elvie Stride is manufactured by Chiaro Technology Limited.
What is the FDA product code for Elvie Stride?
The FDA product code for Elvie Stride is HGX.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.