← Product Code [IMB](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMB) · K810320

# HEATPAC (K810320)

_Shinsei Corp. · IMB · Mar 4, 1981 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMB/K810320

## Device Facts

- **Applicant:** Shinsei Corp.
- **Product Code:** [IMB](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMB.md)
- **Decision Date:** Mar 4, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5250
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMB/K810320](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMB/K810320)

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