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510(k) K231532

Device
ActiGraph LEAP activity monitor (ActiGraph LEAP)
Applicant
Actigraph, LLC
510(k) number
K231532
Product code
LEL
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-23
Date received
2023-05-26
Regulation
882.5050
Classification name
Device, Sleep Assessment
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Brian Bell
Address
70 N. Baylen St., Suite 400 Pensacola FL US 32504 32504

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K181077ActiGraph CentrePoint Insight WatchActigraph2018-05-24
K151784ActTrustCondor Instruments Ltda. - Epp2016-05-25
K132764MOTION WATCH AND PRO-DIARYCamntech, Ltd.2014-01-21
K111514SBV2, MULTICHARGER MODEL MC10V2Sleep Performance D.B.A. Fatigue Science2011-12-16
K040932EASYNET BODY POSITION MODULECadwell Laboratories, Inc.2004-07-01
K040986CADWELL LIMB MOVEMENT MODULECadwell Laboratories, Inc.2004-07-01
K003499REMVIEW SLEEP RECORDER, MODEL 320Respironics, Inc.2001-02-09
K981969ULTIMA BODY POSITION SENSORBraebon Medical Corp.1998-08-20
K961817B SMART MODEL 1Koven Technology, Inc.1997-07-23
K965079SOMNITOR 32K SLEEP ACTIVITY MONITORNeurim Pharmaceuticals, Ltd.1997-07-10