510(k) K110563
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