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510(k) Data Aggregation
K Number
K191876Device Name
PulmoScan
Manufacturer
Cognita Labs, LLC
Date Cleared
2020-03-18
(247 days)
Product Code
PNV
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
Cognita Labs, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PulmoScan is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). PulmoScan is intended for use with pediatic and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers, similarly trained personnel and patients in hospitals, clinics, private physician offices or home.
Device Description
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K Number
K183586Device Name
CapMedic
Manufacturer
Cognita Labs, LLC
Date Cleared
2019-09-13
(266 days)
Product Code
CAF, BZG
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
Cognita Labs, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CapMedic is intended to be used in adults and children 5 years of age and above, who are prescribed CapMedic to be used with their MDIs by their physician.
The CapMedic device is an accessory intended for single-patient use to assist physicians and patients in recording and monitoring the MDI (Metered Dose Inhaler) actuations and conducting PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume for 1 second) spirometry tests. CapMedic measures of MDI use and records it for review by the physician and/or the patient. Furthermore, CapMedic reminds the patient on important steps of MDI use through audio-visual-haptic cues during their MDI use. With the provided PEF/FEV 1 adapter, CapMedic can also perform PEF/FEV1 spirometry test and provides LED feedback based on the measured FEV1. CapMedic can securely transmit MDI usage data and PEF/FEV1 test results to a Bluetooth enabled device running data collection software meeting the CapMedic secure interface protocol over a Bluetooth connection.
CapMedic can be used in the home, work, healthcare, and clinical use environments/settings.
The CapMedic device may also be used in clinical trials where researchers need to know information about the use of MDI medication(s) by a participant.
CapMedic may be used with any of the following MDIs: Ventolin HFA, Advair HFA, Flovent HFA, Xopenex HFA, Symbicort HFA, Atrovent HFA, Proventil HFA, Alvesco HFA, and Asmanex HFA and is attached with a specific adapter for the MDIs.
Device Description
The CapMedic device includes a reusable sensing module that attaches to the Metered Dose Inhaler (MDI) to measure when and how patients use their inhalers. CapMedic has on-board visual, audio and haptic user interfaces (Uls) to remind patients to use their inhaler correctly through Ul prompts. The recorded parameters of MDI use are MDI shaking, orientation, coordination between MDI actuation and the start of inspiration, and inhalation duration. During MDI use, CapMedic can provide just-in-time reminders, in the form of Ul prompts, for various steps of MDI use, namely, MDI shaking, MDI upright orientation, correct coordination, breathe long and hold breath at the end. CapMedic also optionally provides dosing reminders through UI prompts at times preset by the user.
Further, CapMedic has a built-in peak-flow meter functionality with a separate mouthpiece attachment to the bottom of the sensing module to measure peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1). CapMedic can securely transmit MDI usage data and PEF/FEV1 test results to a Bluetooth enabled device running data collection software meeting the CapMedic secure interface protocol over a Bluetooth connection. The CapMedic is powered by a rechargeable Lithium Polymer battery and can be charged via a micro-USB cable.
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