Propeller - The Propeller System includes the OTC Sensor - RECIPROCAL LABS CORPORATION

Duns Number:968712278

Device Description: The Propeller System includes the OTC Sensor Model 2016-M for MDI. The sensor is an access The Propeller System includes the OTC Sensor Model 2016-M for MDI. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage.The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the MDI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers.The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their respiratory medication(s) and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and healthcare providers.When used with a prescribed MDI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing MDI technique.When used under the care of a physician with a prescribed MDI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI or other inhaled medications through the use of feedback such as reminders and notifications, and self-management education.The Propeller System is intended to be used in populations from Child (>2 years) to adult.The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI or other inhaled medication(s) by a participant.

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More Product Details

Catalog Number

-

Brand Name

Propeller

Version/Model Number

Sensor Model 2016-M-L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K142516

Product Code Details

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Device Record Status

Public Device Record Key

37ba1044-4b2a-4069-8bcc-a1ec942c2b9a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 21, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RECIPROCAL LABS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8