21 CFR 868.5180 — Bed, Rocking, Breathing Assist
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 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 Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CCO | Bed, Rocking, Breathing Assist | 2 | 0 | Life-Sustaining |
Special Controls
CCO — Bed, Rocking, Breathing Assist
*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.
eCFR
