← Product Code [IMC](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC) · K833631

# THERMAMED BATH (K833631)

_Bernlit Enterprises, Inc. · IMC · Nov 28, 1983 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC/K833631

## Device Facts

- **Applicant:** Bernlit Enterprises, Inc.
- **Product Code:** [IMC](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC.md)
- **Decision Date:** Nov 28, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5110
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

A paraffin bath is a device intended for medical purposes that consists of a tub to be filled with liquid paraffin (wax) and maintained at an elevated temperature in which the patient's appendages (e.g., hands or fingers) are placed to relieve pain and stiffness.

## 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/IMC/K833631](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC/K833631)

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