PSI BANDS
FDA 510(k) clearance K070766 · decided 2007-07-26
Clearance details
- K-number
- K070766
- Device name
- PSI BANDS
- Applicant
- Psi Health Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-03-20
- Decision date
- 2007-07-26
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- MVV
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Pacific Grove, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
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| PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP (K110563) | Therapeutics 101, Inc (Dba Pressure Point, Inc.) | 2011-04-08 |
| ACUBAND ACUPRESSURE WRIST BAND DEVICE (K053509) | Acuband, Inc. | 2006-08-16 |
| BIOBANDS (K051397) | Biobands Distributors, Inc. | 2005-09-16 |
| EZY-TRAVEL WRISTBAND (K041766) | Apothecary Products, Inc. | 2004-11-26 |
| ACU-STRAP MOTION SICKNESS BAND (K041877) | Health Ent., Inc. | 2004-10-08 |
| SEA-BAND (K033268) | Sea-Band UK , Ltd. | 2004-01-07 |
| ACU-BAND ACCUPRESSURE WRIST BAND (K900588) | Euro-Am Pharma, Inc. | 1990-02-22 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC recall (Z-1821-2008) | Psi Health Solutions | 2008-09-02 |