SAUNETTE, PORTABLE STEAM CABIN
Device Facts
| Record ID | K914234 |
|---|---|
| Device Name | SAUNETTE, PORTABLE STEAM CABIN |
| Applicant | Sauna Magic, Inc. |
| Product Code | IMB · Physical Medicine |
| Decision Date | Feb 11, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5250 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
