Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5250](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5250) → IMB — Cabinet, Moist Steam

# IMB · Cabinet, Moist Steam

_Physical Medicine · 21 CFR 890.5250 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMB

## Overview

- **Product Code:** IMB
- **Device Name:** Cabinet, Moist Steam
- **Regulation:** [21 CFR 890.5250](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5250)
- **Device Class:** 2
- **Review Panel:** [Physical Medicine](/submissions/PM)

## 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](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMB/K003916.md) | DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM | Scandia Manufacturing , Ltd. | Apr 15, 2002 | SESE |
| [K955808](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMB/K955808.md) | DYNA T-2000 PHYSICAL THERAPY SYSTEM | Thermia, Inc. | Nov 3, 1997 | SESE |
| [K914234](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMB/K914234.md) | SAUNETTE, PORTABLE STEAM CABIN | Sauna Magic, Inc. | Feb 11, 1992 | SESE |
| [K810320](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMB/K810320.md) | HEATPAC | Shinsei Corp. | Mar 4, 1981 | SESE |
| [K770086](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMB/K770086.md) | 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

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMB](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMB)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com