← Product Code [IRQ](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRQ) · K832177

# PULSAIR MODEL SP-1 (K832177)

_Thermowave Medical Device Corp. · IRQ · Dec 9, 1983 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRQ/K832177

## Device Facts

- **Applicant:** Thermowave Medical Device Corp.
- **Product Code:** [IRQ](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRQ.md)
- **Decision Date:** Dec 9, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5950
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRQ/K832177](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRQ/K832177)

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