Propeller

The filing identifies Propeller Sensor Model 2014-D as a single-patient accessory for recording and monitoring actuations of prescribed dry powder inhaler use. With a prescribed inhaler,…

Registry build 21.09.26

The filing identifies Propeller Sensor Model 2014-D as a single-patient accessory for recording and monitoring actuations of prescribed dry powder inhaler use.

With a prescribed inhaler, the system can report time between actuations, which the filing says can help assess inhaler technique. Intended users range from children older than two years to adults.

Listed Item

The Propeller System includes the Propeller DPI Model 2014-D Sensor. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI 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 DPI 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 DPI, 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 DPI technique. When used under the care of a physician with a prescribed DPI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to DPI 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.

Sensor Operation

The portable sensor mounts on top of a dry powder inhaler and records inhalation events when medication is used. System output is not intended to diagnose or replace a physician’s diagnosis.

42manufacturers in China registered for this device type
8catalogue numbers in this listing
10510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (23), Jiangsu (7), Fujian (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CAF
Manufacturer City Province Registered as Device types
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Sunmed AP, Ltd. Zhuhai Guangdong Contract manufacturer 18
Polymed (Xiamen) Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 17
Sunmed AP, Ltd., Warehouse NO. 2 Zhuhai Guangdong Contract manufacturer 16
Hangzhou Jinlin Medical Appliances Co., Ltd. Hangzhou Zhejiang Contract manufacturer 11
Shenzhen Huayan E-Commerce Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
Shenzhen BI-Rich Medical Devices Co., Ltd. Shenzhen Guangdong Contract manufacturer 9
Respironics Medical Products (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Omron (Dalian) Co., Ltd. (Plant 1) Dalian Liaoning Contract manufacturer 7
Apex Medical (Kunshan) Corp. Kunshan Jiangsu Contract manufacturer 4
Dongguan Polygreen Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Living Science Co., Ltd. Suzhou Jiangsu Contract manufacturer 3

Showing 12 of 42. All 42 manufacturers in China registered for Nebulizer (Direct Patient Interface)

Record

Regulatory record for Propeller
Listed by Reciprocal Labs Corporation, United States
FDA product code CAF
Device type Nebulizer (Direct Patient Interface)
Device class Class 2
Regulation 21 CFR 868.5630
510(k) K152882
Record published 2016-07-22
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety MR Unsafe
Single use Yes
Over the counter Yes
Label carries manufacturing date, serial number
Storage Storage environment temperature -10 to 60 °C; Handling environment temperature 0 to 55 °C; Storage environment temperature 15 to 140 °F; Handling environment temperature 32 to 130 °F; Handling environment humidity 5 to 95 % RH

Catalogue Numbers

Catalogue numbers for Propeller
Catalogue number Size Status
Sensor Model 2014-D In distribution
Sensor Model 2016-M-L In distribution
Sensor Model 2017-B In distribution
Sensor Model 2014-R In distribution
MDI 2 Sensor In distribution
Sensor Model 2015-E In distribution
Sensor Model 2016-M-S In distribution
Sensor Model 2018-S In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Hudson RCI Teleflex Medical LLC 220
AirLife Carefusion 77
AirLife™ Airlife, Inc. 76
Ventlab Ventlab, LLC 56
I-neb Respironics Respiratory Drug Delivery (Uk), Ltd. 55
Aerogen® Solo Nebulizer System Aerogen Ltd 53
Portex ICU Medical, Inc 50
Sidestream Respironics Respiratory Drug Delivery (Uk), Ltd. 48
Hudson RCI Medline Industries, Inc. 46
DeVilbiss DeVilbiss Healthcare LLC. 45
Drive Drive DeVilbiss Healthcare 42
Drivemedical Drive DeVilbiss Healthcare 40

Showing 12 of 541. All products under Nebulizer (Direct Patient Interface)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K192724 2020-03-26
K180770 2018-08-01
K161454 2016-11-01
K152882 2016-03-08
K152482 2016-03-04
K143671 2015-06-19
K142516 2015-05-15
K142960 2015-03-05
K140638 2014-05-02
K121609 2012-07-02

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer