| Device |
compression-based airway clearance device |
| Regulation Description |
Powered percussor. |
| Definition |
It is intended to support bronchial drainage breathing techniques by providing oscillating regional compression to the thorax. |
| Physical State |
A vest with multiple pressure regions, connected to a control unit that sequentially and repeatedly actuates the regions to apply constricting pressure. |
| Technical Method |
A vest applies compression to the chest and back to generate oscillating pressure promoting regional lung volume restriction and breathing at different lung volumes to generate shearing forces induced by airflow, which loosens, mobilizes, and/or moves mucus from the peripheral to the central airways for expulsion through coughing. |
| Target Area |
The thorax, airway, lungs, and bronchi or bronchial tree. |
| Regulation Medical Specialty |
Anesthesiology |
| Review Panel |
Anesthesiology |
|---|
| Product Code | SDS |
|---|
| Premarket Review |
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
868.5665
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
