§868.5180. Rocking bed.
21 C.F.R. § 868.5180
Identification. A rocking bed is a device intended for temporary use to help patient ventilation (breathing) by repeatedly tilting the patient, thereby using the weight of the abdominal contents to move the diaphragm.
Classification. Class II (special 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.
Notes, amendments, and revision history
Amendments
[47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 47 FR 31142, July 16, 1982, unless otherwise noted.
Amendments
[47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019]