BIOBANDS
FDA 510(k) clearance K051397 · decided 2005-09-16
Clearance details
- K-number
- K051397
- Device name
- BIOBANDS
- Applicant
- Biobands Distributors, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-27
- Decision date
- 2005-09-16
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- MVV
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FridaMom Anti-Nausea Bands (K220289) | Fridababy, LLC | 2022-06-29 |
| Bonine Acupressure Bands (K211823) | Wellspring Pharmaceutical Corporation | 2021-09-01 |
| TumEase Acupressure Bracelets (K193374) | Mumease | 2020-03-04 |
| Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip (K142471) | Pressure Point, Inc. | 2014-12-01 |
| BARF BAND (K110821) | Doodlebug Products, LLC | 2012-02-27 |
| PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP (K110563) | Therapeutics 101, Inc (Dba Pressure Point, Inc.) | 2011-04-08 |
| PSI BANDS (K070766) | Psi Health Solutions, Inc. | 2007-07-26 |
| ACUBAND ACUPRESSURE WRIST BAND DEVICE (K053509) | Acuband, Inc. | 2006-08-16 |
| 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
No recalls on record reference this clearance.