Comfort Cough
Comfort Cough SICC2001 assists patients who cannot clear respiratory secretions effectively because of reduced cough flow. A blower and valve first apply positive pressure to the airway,…
Comfort Cough SICC2001 assists patients who cannot clear respiratory secretions effectively because of reduced cough flow. A blower and valve first apply positive pressure to the airway, then rapidly switch to negative pressure. The resulting outward airflow simulates a cough to help move retained secretions.
The user can adjust pressure, suction and positive flow, with a gauge indicating the applied pressure. The device operates manually or automatically. It connects through a face mask, mouthpiece or an adaptor to an endotracheal or tracheostomy tube.
Listed Item
This COMFORT COUGH (SICC2001) is composed of body part, connection tube, and power cable, providing positive pressure gradually and then turning it into negative pressure fast, to make high expiratory pressure to suck up body fluids (secretion in the respiratory tract) just like when people inhale. This product contains a regulator which can control the pressure and the flow so that the user can setup expiratory pressure, suction pressure, and flow. Also, this product contains Bacterial filter to prevent the inflow of body fluids into the body part of the product.
Use Setting
The device is prescribed for children and adults in institutional or home settings with adequate training. It is not intended for neonates or infants. A compatible separately supplied bacterial filter can be used according to the specified connection requirements.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
Record
| Listed by | Seoil Pacific Corp, South Korea |
|---|---|
| FDA product code | NHJ |
| Device type | Device, Positive Pressure Breathing, Intermittent |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Manufacturer |
| 510(k) | K113549 |
| Record published | 2025-02-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SICC2001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoughAssist | Respironics Inc. | 44 |
| Percussionaire | Percussionaire Corp. | 40 |
| The MetaNeb®System | Hill-Rom Services Pte, Ltd. | 14 |
| The VitalCough®System | Hill-Rom Services Pte, Ltd. | 10 |
| Synclara Cough System | Hill-Rom Services Pte, Ltd. | 10 |
| Volara System | Hill-Rom Services Pte, Ltd. | 9 |
| Vocsn Patient Breathing Package | Ventec Life Systems, Inc. | 7 |
| Clearo | Breas Medical, Inc. | 6 |
| Maximus System | Hill-Rom Services Pte, Ltd. | 6 |
| BiWaze Clear Dual Lumen Circuit With Face Mask – Adult Small | Abmrc LLC | 3 |
| BiWaze Cough Dual Lumen Circuit With Face Mask – Adult Large | Abmrc LLC | 3 |
| The Vest APX System | Hill-Rom Services Pte, Ltd. | 2 |
Showing 12 of 32. All products under Device, Positive Pressure Breathing, Intermittent
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113549 | 2013-02-21 |
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.