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FDA 510(k)

ActiGraph LEAP activity monitor (ActiGraph LEAP)

K-Number: K231532 · 2023-06-23

ApplicantActigraph, LLC
Decision Date2023-06-23
Product CodeLEL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ActiGraph LEAP activity monitor (ActiGraph LEAP) is a medical device manufactured by Actigraph, LLC. It received FDA 510(k) clearance on 2023-06-23 under approval number K231532. The device is classified under product code LEL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ActiGraph LEAP activity monitor (ActiGraph LEAP)?

ActiGraph LEAP activity monitor (ActiGraph LEAP) is a medical device that received FDA 510(k) clearance on 2023-06-23. It is manufactured by Actigraph, LLC. The 510(k) number is K231532.

When was ActiGraph LEAP activity monitor (ActiGraph LEAP) approved by the FDA?

ActiGraph LEAP activity monitor (ActiGraph LEAP) received FDA 510(k) clearance on 2023-06-23, under approval number K231532.

What company makes ActiGraph LEAP activity monitor (ActiGraph LEAP)?

ActiGraph LEAP activity monitor (ActiGraph LEAP) is manufactured by Actigraph, LLC.

What is the FDA product code for ActiGraph LEAP activity monitor (ActiGraph LEAP)?

The FDA product code for ActiGraph LEAP activity monitor (ActiGraph LEAP) is LEL.

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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.

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