← Product Code [IME](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IME) · K915876

# HOTPAD (K915876)

_Ten Comfort Corp. · IME · Feb 12, 1993 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IME/K915876

## Device Facts

- **Applicant:** Ten Comfort Corp.
- **Product Code:** [IME](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IME.md)
- **Decision Date:** Feb 12, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5700
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

A cold pack is a device intended for medical purposes that consists of a compact fabric envelope containing a specially hydrated pliable silicate gel capable of forming to the contour of the body and that provides cold therapy for body surfaces.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IME/K915876](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IME/K915876)

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