21 CFR § 868.5365 - Posture chair for cardiac or pulmonary treatment.
§ 868.5365 Posture chair for cardiac or pulmonary treatment.
(a) 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.
(b) Classification. 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.