IMC · Bath, Paraffin
Physical Medicine · 21 CFR 890.5110 · Class 2
Overview
| Product Code | IMC |
|---|---|
| Device Name | Bath, Paraffin |
| Regulation | 21 CFR 890.5110 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
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 | REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) | Shenzhen Comfort Technology Co., Ltd. | Nov 24, 2009 | SESE |
| K022626 | MOISTURESTAY (REVLON) | Raymond Industrial, Ltd. | Oct 29, 2002 | SESE |
| K013707 | SOFTIQUE, MODEL GI 11001 | Global TV Concepts, Ltd. | Feb 1, 2002 | SESE |
| K013328 | REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 | Remington Products Company, LLC | Dec 3, 2001 | SESE |
| K001860 | PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA | Homedics, Inc. | Aug 10, 2000 | SESE |
| K991427 | PARAMED PARAFFIN WARMER | Divi Intl. Co. | Aug 13, 1999 | SESE |
| K980718 | PARA-CARE | Chattanooga Group, Inc. | Mar 27, 1998 | SESE |
| K861344 | R1124 & R1686 PARAFFIN | Tri W-G, Inc. | May 27, 1986 | SESE |
| K861346 | R1363 PARAFFIN | Tri W-G, Inc. | May 2, 1986 | SESE |
| K842423 | PARA THERM BATH | Grimm Scientific Industries, Inc. | Jun 28, 1984 | SESE |
| K833631 | THERMAMED BATH | Bernlit Enterprises, Inc. | Nov 28, 1983 | SESE |
| K770170 | 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
