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 Apr 8, 2011. The device falls under product code MVV (Device, Acupressure), a Class U device.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 8, 2011
Date Received
Feb 28, 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

Source: FDA 510(k) database entry for K110563. Report a data issue: hello@regdatalab.com.