510(k) K833631
- Device
- THERMAMED BATH
- Applicant
- BERNLIT ENTERPRISES, INC.
- 510(k) number
- K833631
- Product code
- IMC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-11-28
- Date received
- 1983-10-17
- Regulation
- 890.5110
- Classification name
- Bath, Paraffin
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 1222304
- 2118418
- 3017930281
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IMC #
| 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 |
| K770170 | MADDATHERM PARAFFIN BATH | Techhnilab Instruments, Inc. | 1977-01-28 |
Legacy Summary#
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FDA Review#
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