The following data is part of a premarket notification filed by Therapeutics 101, Inc (dba Pressure Point, Inc.) with the FDA for Pressure Right, Single-use, Disposable, Pressure-sensitive Emetic-management Wrist Strip.
| Device ID | K110563 |
| 510k Number | K110563 |
| Device Name: | PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP |
| Classification | Device, Acupressure |
| Applicant | THERAPEUTICS 101, INC (DBA PRESSURE POINT, INC.) 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Contact | Julie Powell |
| Correspondent | Julie Powell THERAPEUTICS 101, INC (DBA PRESSURE POINT, INC.) 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Product Code | MVV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-28 |
| Decision Date | 2011-04-08 |
| Summary: | summary |