21 CFR 868.5665 — Percussor, Powered-Electric
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5665
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BYI | Percussor, Powered-Electric | 2 | 57 | 3rd Party |
| SDS | Compression-Based Airway Clearance Device | 2 | 0 | |
| SDT | Intra-Pulmonary Percussive Vibration (Ipv) Devices | 2 | 3 |