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510(k) K231532

ActiGraph LEAP activity monitor (ActiGraph LEAP) by Actigraph, LLC — Product Code LEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2023
Date Received
May 26, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sleep Assessment
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

Other clearances by Actigraph, LLC

  • K181077 — ActiGraph CentrePoint Insight Watch (May 24, 2018)
  • K080545 — ACTITRAINER (July 24, 2008)

Other clearances for product code LEL

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  • K251574 — Sleep Watch (July 31, 2025)
  • K243513 — DCM (PW-DCM) (April 16, 2025)
  • K233987 — VERABAND™ (June 17, 2024)
  • K233618 — Oxevision Sleep Device (April 3, 2024)
  • K181077 — ActiGraph CentrePoint Insight Watch (May 24, 2018)
  • K151784 — ActTrust (May 25, 2016)
  • K132764 — MOTION WATCH AND PRO-DIARY (January 21, 2014)
  • K111514 — SBV2, MULTICHARGER MODEL MC10V2 (December 16, 2011)
  • K040986 — CADWELL LIMB MOVEMENT MODULE (July 1, 2004)