Device, Acupressure
An Acupressure Device is a device that applies targeted physical pressure to specific acupressure points on the body based on traditional medicine principles, used for the relief of symptoms such as nausea, pain, or stress without penetrating the skin. This device has an unclassified status (class "U") in the FDA database. The product code is MVV with no regulation number assigned, and the device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MVV
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- NE
- Submission Type
- 7
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K220289 | FridaMom Anti-Nausea Bands | Jun 29, 2022 | Substantially Equivalent | Fridababy, LLC |
| K211823 | Bonine Acupressure Bands | Sep 01, 2021 | Substantially Equivalent | Wellspring Pharmaceutical Corporation |
| K193374 | TumEase Acupressure Bracelets | Mar 04, 2020 | Substantially Equivalent | Mumease |
| K142471 | Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip | Dec 01, 2014 | Substantially Equivalent | Pressure Point, Inc. |
| K110821 | BARF BAND | Feb 27, 2012 | Substantially Equivalent | Doodlebug Products, LLC |
| K110563 | PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP | Apr 08, 2011 | Substantially Equivalent | Therapeutics 101, Inc (Dba Pressure Point, Inc.) |
| K070766 | PSI BANDS | Jul 26, 2007 | Substantially Equivalent | Psi Health Solutions, Inc. |
| K053509 | ACUBAND ACUPRESSURE WRIST BAND DEVICE | Aug 16, 2006 | Substantially Equivalent | Acuband, Inc. |
| K051397 | BIOBANDS | Sep 16, 2005 | Substantially Equivalent | Biobands Distributors, Inc. |
| K041766 | EZY-TRAVEL WRISTBAND | Nov 26, 2004 | Substantially Equivalent | Apothecary Products, Inc. |
| K041877 | ACU-STRAP MOTION SICKNESS BAND | Oct 08, 2004 | Substantially Equivalent | Health Ent., Inc. |
| K033268 | SEA-BAND | Jan 07, 2004 | Substantially Equivalent | Sea-Band UK , Ltd. |
| K900588 | ACU-BAND ACCUPRESSURE WRIST BAND | Feb 22, 1990 | Substantially Equivalent | Euro-Am Pharma, Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.