IMB · Cabinet, Moist Steam
Physical Medicine · 21 CFR 890.5250 · Class 2
Overview
| Product Code | IMB |
|---|---|
| Device Name | Cabinet, Moist Steam |
| Regulation | 21 CFR 890.5250 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
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.
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.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K003916 | DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM | Scandia Manufacturing , Ltd. | Apr 15, 2002 | SESE |
| K955808 | DYNA T-2000 PHYSICAL THERAPY SYSTEM | Thermia, Inc. | Nov 3, 1997 | SESE |
| K914234 | SAUNETTE, PORTABLE STEAM CABIN | Sauna Magic, Inc. | Feb 11, 1992 | SESE |
| K810320 | HEATPAC | Shinsei Corp. | Mar 4, 1981 | SESE |
| K770086 | SANAR | Health Improvement Assoc. | Apr 18, 1977 | SESE |
Top Applicants
- Health Improvement Assoc. — 1 clearance
- Sauna Magic, Inc. — 1 clearance
- Scandia Manufacturing , Ltd. — 1 clearance
- Shinsei Corp. — 1 clearance
- Thermia, Inc. — 1 clearance
