510(k) K142471
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