21 CFR 890.5250 — Cabinet, Moist Steam
Physical Medicine (PM) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5250
Identification
A moist steam cabinet is a device intended for medical purposes that delivers a flow of heated, moisturized air to a patient in an enclosed unit. It is used to treat arthritis and fibrosis (a formation of fibrosis tissue) and to increase local blood flow.
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 § 890.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IMB | Cabinet, Moist Steam | 2 | 5 |
Special Controls
IMB — Cabinet, Moist Steam
*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 § 890.9.
eCFR
