The following data is part of a premarket notification filed by Pressure Point Inc. with the FDA for Pressure Right, Single-use, Disposable, Acupressure, Pressure-sensitive Wrist Strip.
Device ID | K142471 |
510k Number | K142471 |
Device Name: | Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip |
Classification | Device, Acupressure |
Applicant | Pressure Point Inc. 936 Green Meadow Drive Tinton Falls, NJ 07724 |
Contact | Joseph Dilustro |
Correspondent | Julie Powell Emergo Group 816 Congress Avenue, Suite 1400 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 | 2014-09-03 |
Decision Date | 2014-12-01 |
Summary: | summary |