510(k) K070766
- Device
- PSI BANDS
- Applicant
- PSI HEALTH SOLUTIONS, INC.
- 510(k) number
- K070766
- Product code
- MVV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-07-26
- Date received
- 2007-03-20
- Regulation
- 510(k) Premarket Notification
- Classification name
- Device, Acupressure
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Neurology
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROMY TAORMINA
- Address
- 606 Lighthouse Ave. #168 Pacific Grove CA US 93950 93950
FDA Registration Numbers#
- 8044105
- 3009155880
- 2000004234
- 3003062321
- 3005630901
- 3009068676
- 2183416
- 3007740394
- 3016195105
Source Documents#
Other 510(k) Records For Product Code MVV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220289 | FridaMom Anti-Nausea Bands | Fridababy, LLC | 2022-06-29 |
| K211823 | Bonine Acupressure Bands | Wellspring Pharmaceutical Corporation | 2021-09-01 |
| K193374 | TumEase Acupressure Bracelets | Mumease | 2020-03-04 |
| K142471 | Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip | Pressure Point, Inc. | 2014-12-01 |
| K110821 | BARF BAND | Doodlebug Products, LLC | 2012-02-27 |
| K110563 | PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP | Therapeutics 101, Inc (Dba Pressure Point, Inc.) | 2011-04-08 |
| K053509 | ACUBAND ACUPRESSURE WRIST BAND DEVICE | Acuband, Inc. | 2006-08-16 |
| K051397 | BIOBANDS | Biobands Distributors, Inc. | 2005-09-16 |
| K041766 | EZY-TRAVEL WRISTBAND | Apothecary Products, Inc. | 2004-11-26 |
| K041877 | ACU-STRAP MOTION SICKNESS BAND | Health Ent., Inc. | 2004-10-08 |
| K033268 | SEA-BAND | Sea-Band UK , Ltd. | 2004-01-07 |
| K900588 | ACU-BAND ACCUPRESSURE WRIST BAND | Euro-Am Pharma, Inc. | 1990-02-22 |
Legacy Summary#
summary
FDA Review#
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