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 CodeDevice NameClassDevicesAttributes
BYNChair, Posture, For Cardiac And Pulmonary Treatment11
Innolitics

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