Code of Federal Regulations · Section

§ 868.5365 — Posture Chair For Cardiac Or Pulmonary Treatment

21 C.F.R. § 868.5365

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(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.

Authorizing Statute