SDT · Intra-Pulmonary Percussive Vibration (Ipv) Devices
Anesthesiology · 21 CFR 868.5665 · Class 2
Overview
| Product Code | SDT |
|---|---|
| Device Name | Intra-Pulmonary Percussive Vibration (Ipv) Devices |
| Regulation | 21 CFR 868.5665 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
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.
Classification Rationale
Class II (performance standards).
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241091 | SIMEOX 200 Airway Clearance Device | Inogen, Inc. | Dec 23, 2024 | SESE |
| K133057 | VIBRALUNG ACOUSTICAL PERCUSSOR | Westmed, Inc. | May 23, 2014 | SESE |
| K122111 | RESPIRONICS SIMPLYCLEAR DEVICE | Respironics, Inc. | Dec 31, 2012 | SESE |
Top Applicants
- Westmed, Inc. — 1 clearance
- Respironics, Inc. — 1 clearance
- Inogen, Inc. — 1 clearance
