BREATH SHAKE
Device Facts
| Record ID | K121587 |
|---|---|
| Device Name | BREATH SHAKE |
| Applicant | Cheen Houng Ent. Co. , Ltd. |
| Product Code | BYI · Anesthesiology |
| Decision Date | Nov 22, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5665 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.