IMC — Bath, Paraffin Class II
FDA product code IMC covers "Bath, Paraffin", a Class II medical device regulated under 21 CFR 890.5110. Submissions are reviewed by the Physical Medicine panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IMC
- Device Class
- Class II
- Regulation Number
- 890.5110
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K093100 | shenzhen comfort technology co | REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) | November 24, 2009 |
| K022626 | raymond industrial | MOISTURESTAY (REVLON) | October 29, 2002 |
| K013707 | global tv concepts | SOFTIQUE, MODEL GI 11001 | February 1, 2002 |
| K013328 | remington products company | REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 | December 3, 2001 |
| K001860 | homedics | PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA | August 10, 2000 |
| K991427 | divi intl | PARAMED PARAFFIN WARMER | August 13, 1999 |
| K980718 | chattanooga group | PARA-CARE | March 27, 1998 |
| K861344 | tri w-g | R1124 & R1686 PARAFFIN | May 27, 1986 |
| K861346 | tri w-g | R1363 PARAFFIN | May 2, 1986 |
| K842423 | grimm scientific industries | PARA THERM BATH | June 28, 1984 |
| K833631 | bernlit enterprises | THERMAMED BATH | November 28, 1983 |
| K770170 | techhnilab instruments | MADDATHERM PARAFFIN BATH | January 28, 1977 |