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510(k) K053509

ACUBAND ACUPRESSURE WRIST BAND DEVICE by Acuband, Inc. — Product Code MVV

K053509 is an FDA 510(k) premarket notification submitted by Acuband, Inc. for the device "ACUBAND ACUPRESSURE WRIST BAND DEVICE". The FDA issued a decision of Substantially Equivalent on August 16, 2006. The device falls under product code MVV (Device, Acupressure), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2006
Date Received
December 16, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Acupressure
Device Class
Class U
Regulation Number
Review Panel
NE
Submission Type

Other clearances for product code MVV

  • K220289 — FridaMom Anti-Nausea Bands (June 29, 2022)
  • K211823 — Bonine Acupressure Bands (September 1, 2021)
  • K193374 — TumEase Acupressure Bracelets (March 4, 2020)
  • K142471 — Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist St (December 1, 2014)
  • K110821 — BARF BAND (February 27, 2012)
  • K110563 — PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRI (April 8, 2011)
  • K070766 — PSI BANDS (July 26, 2007)
  • K051397 — BIOBANDS (September 16, 2005)
  • K041766 — EZY-TRAVEL WRISTBAND (November 26, 2004)
  • K041877 — ACU-STRAP MOTION SICKNESS BAND (October 8, 2004)

FDA data resources