Product code SDS

Device name
Compression-Based Airway Clearance Device
Medical specialty
Anesthesiology
Device class
2
Regulation number
868.5665
Review panel
AN
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
It is intended to support bronchial drainage breathing techniques by providing oscillating regional compression to the thorax.
Source
FDA openFDA device classification dataset