← Product Code [IMD](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD) · K951383

# TEMPRA HEAT PACK (K951383)

_Tempra Technology, Inc. · IMD · Jun 1, 1995 · Physical Medicine · SN_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K951383

## Device Facts

- **Applicant:** Tempra Technology, Inc.
- **Product Code:** [IMD](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD.md)
- **Decision Date:** Jun 1, 1995
- **Decision:** SN
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5710
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K951383](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMD/K951383)

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