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510(k) K110821

BARF BAND by Doodlebug Products, LLC — Product Code MVV

K110821 is an FDA 510(k) premarket notification submitted by Doodlebug Products, LLC for the device "BARF BAND". The FDA issued a decision of Substantially Equivalent on Feb 27, 2012. The device falls under product code MVV (Device, Acupressure), a Class U device.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 27, 2012
Date Received
Mar 24, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Device, Acupressure
Device Class
Class U
Review Panel
NE
Submission Type
Enforcement Discretion

Other clearances for product code MVV

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  • K211823 — Bonine Acupressure Bands (Sep 1, 2021)
  • K193374 — TumEase Acupressure Bracelets (Mar 4, 2020)
  • K142471 — Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist… (Dec 1, 2014)
  • K110563 — PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT… (Apr 8, 2011)
  • K070766 — PSI BANDS (Jul 26, 2007)
  • K053509 — ACUBAND ACUPRESSURE WRIST BAND DEVICE (Aug 16, 2006)
  • K051397 — BIOBANDS (Sep 16, 2005)
  • K041766 — EZY-TRAVEL WRISTBAND (Nov 26, 2004)
  • K041877 — ACU-STRAP MOTION SICKNESS BAND (Oct 8, 2004)

FDA data resources

Source: FDA 510(k) database entry for K110821. Report a data issue: hello@regdatalab.com.