21 C.F.R. § 868.5365
Posture chair for cardiac or pulmonary treatment.
Cite as 21 C.F.R. § 868.5365 (2026)
(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. [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38794, July 25, 2001]
- Cross-references to the CFR
- 868.9.