Home / 510(k) Clearances / K233987

510(k) K233987

VERABAND™ by Arbor Medical Innovations, LLC — Product Code LEL

K233987 is an FDA 510(k) premarket notification submitted by Arbor Medical Innovations, LLC for the device "VERABAND™". The FDA issued a decision of Substantially Equivalent on June 17, 2024. The device falls under product code LEL (Device, Sleep Assessment), a Class II device regulated under 21 CFR 882.5050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2024
Date Received
December 18, 2023
Clearance Type
Traditional
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 for product code LEL

  • K252981 — EmbraceMini (December 22, 2025)
  • K251574 — Sleep Watch (July 31, 2025)
  • K243513 — DCM (PW-DCM) (April 16, 2025)
  • K233618 — Oxevision Sleep Device (April 3, 2024)
  • K231532 — ActiGraph LEAP activity monitor (ActiGraph LEAP) (June 23, 2023)
  • 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)
  • K040932 — EASYNET BODY POSITION MODULE (July 1, 2004)

FDA data resources