Bath, Paraffin
A Paraffin Bath is a Physical Medicine thermal therapy device containing heated liquid paraffin wax into which the hands, feet, or other body parts are dipped to deliver sustained superficial heat, commonly used in the treatment of arthritis, stiffness, and chronic pain in extremities. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is IMC, regulated under 21 CFR 890.5110, within the Physical Medicine medical specialty.
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Basic Information
- Product Code
- IMC
- Device Class
- FDA class 2
- Regulation Number
- 890.5110
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K093100 | REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) | Nov 24, 2009 | Substantially Equivalent | Shenzhen Comfort Technology Co., Ltd. |
| K022626 | MOISTURESTAY (REVLON) | Oct 29, 2002 | Substantially Equivalent | Raymond Industrial, Ltd. |
| K013707 | SOFTIQUE, MODEL GI 11001 | Feb 01, 2002 | Substantially Equivalent | Global TV Concepts, Ltd. |
| K013328 | REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 | Dec 03, 2001 | Substantially Equivalent | Remington Products Company, LLC |
| K001860 | PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA | Aug 10, 2000 | Substantially Equivalent | Homedics, Inc. |
| K991427 | PARAMED PARAFFIN WARMER | Aug 13, 1999 | Substantially Equivalent | Divi Intl. Co. |
| K980718 | PARA-CARE | Mar 27, 1998 | Substantially Equivalent | Chattanooga Group, Inc. |
| K861344 | R1124 & R1686 PARAFFIN | May 27, 1986 | Substantially Equivalent | Tri W-G, Inc. |
| K861346 | R1363 PARAFFIN | May 02, 1986 | Substantially Equivalent | Tri W-G, Inc. |
| K842423 | PARA THERM BATH | Jun 28, 1984 | Substantially Equivalent | Grimm Scientific Industries, Inc. |
| K833631 | THERMAMED BATH | Nov 28, 1983 | Substantially Equivalent | Bernlit Enterprises, Inc. |
| K770170 | MADDATHERM PARAFFIN BATH | Jan 28, 1977 | Substantially Equivalent | Techhnilab Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.