Cabinet, Moist Steam
A Moist Steam Cabinet is a Physical Medicine device that generates a steam environment within an enclosure to deliver whole-body or regional moist heat therapy, used to promote muscle relaxation, increase tissue extensibility, and prepare patients for exercise or manual therapy. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is IMB, regulated under 21 CFR 890.5250, within the Physical Medicine medical specialty.
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Basic Information
- Product Code
- IMB
- Device Class
- FDA class 2
- Regulation Number
- 890.5250
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K003916 | DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM | Apr 15, 2002 | Substantially Equivalent | Scandia Manufacturing , Ltd. |
| K955808 | DYNA T-2000 PHYSICAL THERAPY SYSTEM | Nov 03, 1997 | Substantially Equivalent | Thermia, Inc. |
| K914234 | SAUNETTE, PORTABLE STEAM CABIN | Feb 11, 1992 | Substantially Equivalent | Sauna Magic, Inc. |
| K810320 | HEATPAC | Mar 04, 1981 | Substantially Equivalent | Shinsei Corp. |
| K770086 | SANAR | Apr 18, 1977 | Substantially Equivalent | Health Improvement Assoc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.