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Found 12 results
510(k) Data Aggregation
K Number
K220289Device Name
FridaMom Anti-Nausea Bands
Manufacturer
FridaBaby LLC
Date Cleared
2022-06-29
(148 days)
Product Code
MVV
Regulation Number
N/AWhy did this record match?
Product Code :
MVV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FridaMom Anti-Nausea Bands are intended to reduce symptoms of nausea which may be experienced due to Travel/ Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).
Device Description
The FridaMom Anti-nausea Bands are adjustable wrist bands which apply pressure to the Neiguan (P6) acupressure point to relive symptoms of nausea. The bands consist of an adjustable strap with a hemi-spherical button which applies pressure to the acupressure point.
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K Number
K211823Device Name
Bonine Acupressure Bands
Manufacturer
WellSpring Pharmaceutical Corporation
Date Cleared
2021-09-01
(79 days)
Product Code
MVV
Regulation Number
N/AWhy did this record match?
Product Code :
MVV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bonine Acupressure Bands are intended to reduce symptoms of nausea. Nausea may be experienced due to Travel/ Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).
Device Description
Bonine Acupressure Bands are acupressure devices made of comfortable fabric band straps with Velcro closures and a dome on the buckle. Bonine Acupressure Band's acupressure dome provides gentle pressure on the Nei-Kuan or P6 pressure point in the wrist. The amount of pressure applied is fully adjustable and allows the user to increase or decrease as needed. Bonine Acupressure Bands are provided for over-the-counter use to be worn directly as desired on the consumer's wrists.
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K Number
K193374Device Name
TumEase Acupressure Bracelets
Manufacturer
MumEase
Date Cleared
2020-03-04
(90 days)
Product Code
MVV
Regulation Number
N/AWhy did this record match?
Product Code :
MVV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The acupressure bracelets are intended to reduce symptoms of nausea. Nausea may be experienced due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).
Device Description
The TumEase Acupressure bracelet is a wrist bracelet that has a small round bump on the inside face of the bracelet. This small bump is manually aligned with the P6 (Neiguan or Pericardium) acupressure point. The bracelet is affixed using a Velcro strap and the desire amount of pressure is applied. One key design feature is the ability to adjust the pressure level using the "tightness" of the Velcro strap. More pressure generally increases the desired anti-nausea affect. The functionality of the Veloro strap allows each patient the ability to find the right amount of pressure for themselves based on their condition and needs. In addition, the TumEase bracelets are designed to be cosmetically attractive. It is supplied to the counter (non-sterile). The acupressure bracelets are intended to be worn over a thin fabric. It can be used as frequently as needed by the patient.
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K Number
K142471Device Name
Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip
Manufacturer
Pressure Point Inc.
Date Cleared
2014-12-01
(89 days)
Product Code
MVV
Regulation Number
N/AWhy did this record match?
Product Code :
MVV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pressure Right® is a drug-free, Single-Use, Pressure Wrist Strip, externally applied, which is indicated for relief of nausea symptoms associated with chemotherapy, post-operative, pregnancy (morning sickness) and travel/motion.
Device Description
The Pressure Right device is a single-use, disposable acupressure strip that operates by exerting pressure on the Nei-Kuan (acupuncture) or (P6) pressure point.
The Pressure Right device has a three-quarter wrist size design (5.50″ long X 1.0″ wide) with an affixed hard plastic button. Its pressure stimulation effect to the P6 acupressure point provides nausea and vomiting relief for surgical patients. Pressure Right device is intended for use by adults, 18 years and older and intended to be worn on each wrist. The Pressure Right device also comes with a P6 locator template to accurately determine an individual's P6 pressure point.
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K Number
K110821Device Name
BARF BAND
Manufacturer
DOODLEBUG PRODUCTS, LLC
Date Cleared
2012-02-27
(340 days)
Product Code
MVV
Regulation Number
N/AWhy did this record match?
Product Code :
MVV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Barf Band is indicated for the relief of nausea. Nausea is a symptom that may be experienced due to a variety of causes, for example: pregnancy (morning sickness), motion sickness, anesthesia and chemotherapy.
Device Description
The Barf Band is a wristband with adjustable properties that operates by putting pressure on Nei Kuan acupressure point (also known as the P6 point) on each wrist by means of a plastic dome/stud. Barf Bands are made from PVC free polyurethane, ABS plastic covered with Santoprene and 100% cotton. The band itself is composed of polyurethane. The ABS plastic covered with Santoprene is used to construct the plastic dome/stud that applies the pressure to the P6 point. The cotton is used inside the band to make the band comfortable to the end user.
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K Number
K110563Device Name
PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP
Manufacturer
THERAPEUTICS 101, INC (DBA PRESSURE POINT, INC.)
Date Cleared
2011-04-08
(39 days)
Product Code
MVV
Regulation Number
N/AWhy did this record match?
Product Code :
MVV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip is indicated for the relief of emetic (nausea and vomiting) symptoms associated with Post-Operative Anesthesia.
Device Description
The Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip is a single-use, disposable acupressure strip that operates by exerting pressure on the Nei-Kuan (acupuncture) or (P6) pressure point.
The Pressure Right® device has a three-quarter wrist size design (5.50″ long X 1.0″ with an affixed hard plastic button. Its pressure stimulation effect to the P6 acupressure point provides nausea and vomiting relief for surgical patients. Pressure Right® device is intended for use by adults, 18 years and older and intended to be worn on each wrist. The Pressure Right® device also comes with a P6 locator template to accurately determine an individual's P6 pressure point.
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K Number
K070766Device Name
PSI BANDS
Manufacturer
PSI HEALTH SOLUTIONS, INC.
Date Cleared
2007-07-26
(128 days)
Product Code
MVV
Regulation Number
N/AWhy did this record match?
Product Code :
MVV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Psi Bands are indicated for the relief of nausea. Nausea is a symptom that may be experienced due to a variety of causes, for example:
- pregnancy (morning sickness)
- motion sickness
- anesthesia
- chemotherapy.
Psi Bands are intended for over-the-counter use.
Device Description
Psi Bands, acupressure (pressure stimulation) wrist bands, consist of a plastic orb that applies pressure to the Nei-kuan (P6) acupressure point, the area that provides nausea relief. Psi Bands may be worn on both wrists at the same time and may be adjusted at two areas: 1) around the wrist like a watch, and 2) at the acupressure point by turning a plastic dial clock-wise. The plastic dial allows the user to apply different degrees of pressure at the acupressure point for maximum comfort and effectiveness. Select from one of three settings (mild nausea = low pressure; moderate nausea = medium pressure; troublesome nausea = high pressure). By turning the dial past the highest setting, the dial will automatically return to its neutral, or lowest, setting so that it cannot be overtightened.
Psi Bands are made from synthetic rubber, specifically medical grade Santoprene™ thermoplastic rubber and food grade ABS plastic which does not directly contact the patient after adjustment.
Components of the system include:
Strap and collar made of medical grade Santoprene™ thermoplastic rubber
Button is composed of three parts; the dial, the nut and the ring all made of food grade ABS plastic and which reside inside the button itself which is part of the Santoprene™strap
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K Number
K053509Device Name
ACUBAND ACUPRESSURE WRIST BAND DEVICE
Manufacturer
ACUBAND INC.
Date Cleared
2006-08-16
(243 days)
Product Code
MVV
Regulation Number
N/AWhy did this record match?
Product Code :
MVV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acubands are indicated for the relief of nausea. Nausea is a symptom which can be experienced by causes such as motion sickness, morning sickness (pregnancy), chemotherapy and post-operative from anesthesia.
Device Description
The Acubands consist of a pair of wrist bands with a half-round button affixed to the interior side of the band. The Acubands are made of hook and loop fabric which allows the wrist band to be fully adjustable. The Acuband wrist bands enable the button to apply gentle pressure on the acupressure point, the P6 or Nei-Kuan, point on the inner wrist. This action interrupts the signal that triggers nauses.
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K Number
K051397Device Name
BIOBANDS
Manufacturer
BIOBANDS DISTRIBUTORS, INC.
Date Cleared
2005-09-16
(112 days)
Product Code
MVV
Regulation Number
N/AWhy did this record match?
Product Code :
MVV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BioBands is indicated for the relief of nausea. Nausea may be experienced due to a variety of causes, including Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia (Post-Operative) or Chemotherapy.
Device Description
BioBands is an adjustable wristband that fits on either wrist. The device is composed from nylon and polyester fabric, and features a Velcro closure for easy adjustment. The BioBands wristband has a wooden bead or button sewn into the band's underside. When BioBands is worn by users, the wooden bead applies pressure to the P6 or "nei-kuan" acupuncture point. The gentle pressure applied by the bead to the P6 interrupts the signals that trigger nausea.
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K Number
K041766Device Name
EZY-TRAVEL WRISTBAND
Manufacturer
APOTHECARY PRODUCTS, INC.
Date Cleared
2004-11-26
(149 days)
Product Code
MVV
Regulation Number
N/AWhy did this record match?
Product Code :
MVV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the relief of nausea. Nausea may be caused by motion, morning sickness, chemotherapy or anesthesia.
Device Description
Not Found
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