Product code IMC
- Device name
- Bath, Paraffin
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5110
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K093100 | REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) | Shenzhen Comfort Technology Co., Ltd. | 2009-11-24 |
| K022626 | MOISTURESTAY (REVLON) | Raymond Industrial, Ltd. | 2002-10-29 |
| K013707 | SOFTIQUE, MODEL GI 11001 | Global TV Concepts, Ltd. | 2002-02-01 |
| K013328 | REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 | Remington Products Company, LLC | 2001-12-03 |
| K001860 | PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA | Homedics, Inc. | 2000-08-10 |
| K991427 | PARAMED PARAFFIN WARMER | Divi Intl. Co. | 1999-08-13 |
| K980718 | PARA-CARE | Chattanooga Group, Inc. | 1998-03-27 |
| K861344 | R1124 & R1686 PARAFFIN | Tri W-G, Inc. | 1986-05-27 |
| K861346 | R1363 PARAFFIN | Tri W-G, Inc. | 1986-05-02 |
| K842423 | PARA THERM BATH | Grimm Scientific Industries, Inc. | 1984-06-28 |
| K833631 | THERMAMED BATH | Bernlit Enterprises, Inc. | 1983-11-28 |
| K770170 | MADDATHERM PARAFFIN BATH | Techhnilab Instruments, Inc. | 1977-01-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00885914070932 | Performa | Performance Health Supply, LLC | 2025-03-26 |
| 00074108165213 | Conair | CONAIR CORPORATION | 2023-07-07 |
| 00074108171023 | Conair | CONAIR CORPORATION | 2023-07-07 |
| 00074108400703 | UP & UP | TARGET CORPORATION | 2021-08-27 |
| 00702173122755 | Therabath | WR MEDICAL ELECTRONICS CO INC | 2020-03-11 |
| 00702173122809 | Therabath | WR MEDICAL ELECTRONICS CO INC | 2019-11-06 |
| 00074108381101 | CONAIR CORPORATION | CONAIR CORPORATION | 2019-05-03 |
| 00645724004189 | Dickson Paraffin Bath | Whitehall Manufacturing Co | 2019-02-12 |
| 00645724004240 | Whitehall Thermalators | Whitehall Manufacturing Co | 2019-02-12 |
| 00645724004233 | Whitehall Thermalator | Whitehall Manufacturing Co | 2019-02-12 |
| 00645724004226 | Thermasplint | Whitehall Manufacturing Co | 2019-02-12 |
| 00645724004219 | Whitehall Thermalators | Whitehall Manufacturing Co | 2019-02-12 |
| 00645724004202 | Whitehall Thermalators | Whitehall Manufacturing Co | 2019-02-12 |
| 00645724004196 | Dickson Paraffin Bath | Whitehall Manufacturing Co | 2019-02-12 |
| 00645724004172 | Dickson Paraffin Bath | Whitehall Manufacturing Co | 2019-02-12 |
| 00645724004165 | Dickson Paraffin Bath | Whitehall Manufacturing Co | 2019-02-12 |
| 00645724004158 | Dickson Paraffin Bath | Whitehall Manufacturing Co | 2019-02-12 |
| 00645724004141 | Dickson Paraffin Bath | Whitehall Manufacturing Co | 2019-02-12 |
| 00645724004134 | Dickson Paraffin Bath | Whitehall Manufacturing Co | 2019-02-12 |
| 00645724004127 | Dickson Paraffin Bath | Whitehall Manufacturing Co | 2019-02-12 |
| 00645724004110 | Dickson Paraffin Bath | Whitehall Manufacturing Co | 2019-02-12 |
| 00645724004103 | Dickson Paraffin Bath | Whitehall Manufacturing Co | 2019-02-12 |
| 00645724004097 | Dickson Paraffin Bath | Whitehall Manufacturing Co | 2019-02-12 |
| 00645724004080 | Dickson Paraffin Bath | Whitehall Manufacturing Co | 2019-02-12 |
| 00074108371843 | CONAIR | CONAIR CORPORATION | 2018-04-09 |
| 00074108260468 | CONAIR | CONAIR CORPORATION | 2018-02-16 |
| 00074108359650 | CONAIR | CONAIR CORPORATION | 2018-02-16 |
| 00087453240504 | Parabath | HYGENIC CORPORATION, THE | 2016-09-01 |
| 30087453240505 | Parabath | HYGENIC CORPORATION, THE | 2016-09-01 |
| 00861047000329 | PARATherm | GRIMM SCIENTIFIC INDUSTRIES INC | 2016-08-14 |