Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5110](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5110) → IMC — Bath, Paraffin

# IMC · Bath, Paraffin

_Physical Medicine · 21 CFR 890.5110 · Class 2_

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

## Overview

- **Product Code:** IMC
- **Device Name:** Bath, Paraffin
- **Regulation:** [21 CFR 890.5110](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5110)
- **Device Class:** 2
- **Review Panel:** [Physical Medicine](/submissions/PM)

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K093100](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC/K093100.md) | REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) | Shenzhen Comfort Technology Co., Ltd. | Nov 24, 2009 | SESE |
| [K022626](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC/K022626.md) | MOISTURESTAY (REVLON) | Raymond Industrial, Ltd. | Oct 29, 2002 | SESE |
| [K013707](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC/K013707.md) | SOFTIQUE, MODEL GI 11001 | Global TV Concepts, Ltd. | Feb 1, 2002 | SESE |
| [K013328](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC/K013328.md) | REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 | Remington Products Company, LLC | Dec 3, 2001 | SESE |
| [K001860](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC/K001860.md) | PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA | Homedics, Inc. | Aug 10, 2000 | SESE |
| [K991427](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC/K991427.md) | PARAMED PARAFFIN WARMER | Divi Intl. Co. | Aug 13, 1999 | SESE |
| [K980718](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC/K980718.md) | PARA-CARE | Chattanooga Group, Inc. | Mar 27, 1998 | SESE |
| [K861344](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC/K861344.md) | R1124 & R1686 PARAFFIN | Tri W-G, Inc. | May 27, 1986 | SESE |
| [K861346](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC/K861346.md) | R1363 PARAFFIN | Tri W-G, Inc. | May 2, 1986 | SESE |
| [K842423](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC/K842423.md) | PARA THERM BATH | Grimm Scientific Industries, Inc. | Jun 28, 1984 | SESE |
| [K833631](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC/K833631.md) | THERMAMED BATH | Bernlit Enterprises, Inc. | Nov 28, 1983 | SESE |
| [K770170](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC/K770170.md) | MADDATHERM PARAFFIN BATH | Techhnilab Instruments, Inc. | Jan 28, 1977 | SESE |

## Top Applicants

- Tri W-G, Inc. — 2 clearances
- Bernlit Enterprises, Inc. — 1 clearance
- Chattanooga Group, Inc. — 1 clearance
- Divi Intl. Co. — 1 clearance
- Global TV Concepts, Ltd. — 1 clearance

---

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

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