21 CFR 890.5170 — Bed, Flotation Therapy, Powered
Physical Medicine (PM) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5170
Identification
A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.
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 § 890.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IOQ | Bed, Flotation Therapy, Powered | 2 | 57 | |
| MOC | Cushion, Flotation, Therapeutic | 2 | 2 |
Special Controls
IOQ — Bed, Flotation Therapy, Powered
*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 § 890.9.
eCFR
MOC — Cushion, Flotation, Therapeutic
*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 § 890.9.
eCFR
