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510(k) Data Aggregation
K Number
K172956Device Name
Medicant Mucosal Atomizer
Manufacturer
Medica Holdings, LLC
Date Cleared
2018-04-06
(192 days)
Product Code
CCT
Regulation Number
868.5170Why did this record match?
Applicant Name (Manufacturer) :
Medica Holdings, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medicant Mucosal Atomizer is intended for the application of topical anesthetics to the oropharynx and upper airway region.
Device Description
The proposed device delivers the solution through the nasal passages, directly to the laryngo-tracheal region via a wand-like configuration of the device is placed inside an endotracheal tube for a directed spray. The device is offered in 3 configurations, all supplied with a 3 cc syringe.
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K Number
K163091Device Name
VibraPEP
Manufacturer
Medica Holdings, LLC
Date Cleared
2017-02-21
(109 days)
Product Code
BWF
Regulation Number
868.5690Why did this record match?
Applicant Name (Manufacturer) :
Medica Holdings, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VibraPEP™ Mucus Clearing Device is a Positive Expiratory Pressure, PEP device. It was designed to exercise patient's lungs and to improve secretion clearance. The device may be connected via a Valved T-adapter for use with a jet nebulizer for aerosol drug delivery. The VibraPEP™ Mucus Clearing Device is not intended to be used while connected to a jet nebulizer which is delivering nebulized steroidal drugs or antibiotics.
Device Description
The proposed device is the identical VibraPEP™ cleared under K153441 but with a Valved T-adapter and mouthpiece that allow the user to connect a general purpose jet nebulizer.
The VibraPEP™ is an Oscillatory PEP (OPEP) device that looks like a curved shaped pipe with a plastic mouthpiece at one end. A long hose is attached inside. As the patient blows through the VibraPEP™, the hose pressure increases and buckles at the bending of the tube. When the peak pressure is reached, the hose end opens and is catapulted against the wall releasing its pressure. This process is repeated, providing an oscillation effect with pressure during the exhalation phase. By rotating the therapy selector, pressure and flow can be adjusted to achieve optimal therapy for each patient. The VibraPEP™ facilitates mucus clearing by generating and delivering an oscillation effect that vibrates the airways and lung secretions, causing lung secretions to thin and become expelled.
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K Number
K153441Device Name
VibraPEP
Manufacturer
Medica Holdings, LLC
Date Cleared
2016-03-25
(119 days)
Product Code
BWF
Regulation Number
868.5690Why did this record match?
Applicant Name (Manufacturer) :
Medica Holdings, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VibraPEP™ Mucus Clearing Device is a Positive Expiratory Pressure, PEP Device. It was designed to exercise patient's lungs and to improve secretion clearance.
Patient - Patients who have been prescribed PEP therapy
Environment - Hospital, clinics, physician offices, home setting
Device Description
The VibraPEP™ is a Positive End Expiratory (PEP) device in which the user exhales through the device and the device generates expiratory pressure (resistance) and the Tube Valve oscillates creates a range of frequencies within the air column to the patient which help to promote secretion clearance. The VibraPEP™ has been designed to be very similar to the predicate RC-Cornet device (K983308). The basic design, form, function and performance have been compared to the predicate and have been demonstrated to be functionally equivalent and with the same intended use as the predicate.
The device is comprised of several components:
- Curved tube
- Cap for end of Tube ●
- Mouthpiece with selector ●
- Valve tube
- Drying tool ●
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