21 CFR 868.5365 — Chair, Posture, For Cardiac And Pulmonary Treatment
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5365
Identification
A posture chair for cardiac or pulmonary treatment is a device intended to assist in the rehabilitation and mobilization of patients with chronic heart or lung disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BYN | Chair, Posture, For Cardiac And Pulmonary Treatment | 1 | 1 |