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510(k) K142471

Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip by Pressure Point, Inc. — Product Code MVV

K142471 is an FDA 510(k) premarket notification submitted by Pressure Point, Inc. for the device "Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip". The FDA issued a decision of Substantially Equivalent on December 1, 2014. The device falls under product code MVV (Device, Acupressure), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2014
Date Received
September 3, 2014
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

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  • K211823 — Bonine Acupressure Bands (September 1, 2021)
  • K193374 — TumEase Acupressure Bracelets (March 4, 2020)
  • 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)
  • K051397 — BIOBANDS (September 16, 2005)
  • K041766 — EZY-TRAVEL WRISTBAND (November 26, 2004)
  • K041877 — ACU-STRAP MOTION SICKNESS BAND (October 8, 2004)

FDA data resources