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510(k) K110563

PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP by Therapeutics 101, Inc (Dba Pressure Point, Inc.) — Product Code MVV

K110563 is an FDA 510(k) premarket notification submitted by Therapeutics 101, Inc (Dba Pressure Point, Inc.) for the device "PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP". The FDA issued a decision of Substantially Equivalent on April 8, 2011. The device falls under product code MVV (Device, Acupressure), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2011
Date Received
February 28, 2011
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)
  • K142471 — Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist St (December 1, 2014)
  • K110821 — BARF BAND (February 27, 2012)
  • 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