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 Dec 1, 2014. The device falls under product code MVV (Device, Acupressure), a Class U device.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 1, 2014
Date Received
Sep 3, 2014
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 K142471. Report a data issue: hello@regdatalab.com.