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510(k) K051397

BIOBANDS by Biobands Distributors, Inc. — Product Code MVV

K051397 is an FDA 510(k) premarket notification submitted by Biobands Distributors, Inc. for the device "BIOBANDS". The FDA issued a decision of Substantially Equivalent on September 16, 2005. The device falls under product code MVV (Device, Acupressure), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2005
Date Received
May 27, 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

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  • 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)
  • K053509 — ACUBAND ACUPRESSURE WRIST BAND DEVICE (August 16, 2006)
  • K041766 — EZY-TRAVEL WRISTBAND (November 26, 2004)
  • K041877 — ACU-STRAP MOTION SICKNESS BAND (October 8, 2004)

FDA data resources