| Device Type ID | 51 |
| Device Name | Percussor, Powered-electric |
| Regulation Description | Powered Percussor. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5665 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BYI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 51 |
| Device | Percussor, Powered-electric |
| Product Code | BYI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Percussor. |
| CFR Regulation Number | 868.5665 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HILL-ROM SERVICES PTE LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HILL-ROM, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WESTMED HOLDING CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WESTMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 8 |
Battery Problem | 1 |
Pressure Problem | 1 |
| Total Device Problems | 10 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aptalis Pharmatech Inc. | II | Jan-22-2015 |
| 2 | HILL-ROM MANUFACTURING, INC. | II | Nov-30-2017 |