Cleared Special

ActiGraph LEAP activity monitor (ActiGraph LEAP)

K231532 · Actigraph, LLC · Neurology
Jun 2023
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K231532 is an FDA 510(k) clearance for the ActiGraph LEAP activity monitor (ActiGraph LEAP), a Device, Sleep Assessment (Class II — Special Controls, product code LEL), submitted by Actigraph, LLC (Pensacola, US). The FDA issued a Cleared decision on June 23, 2023, 28 days after receiving the submission on May 26, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K231532 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2023
Decision Date June 23, 2023
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code LEL — Device, Sleep Assessment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5050