510(k) K013328
- Device
- REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600
- Applicant
- REMINGTON PRODUCTS COMPANY, L.L.C.
- 510(k) number
- K013328
- Product code
- IMC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-12-03
- Date received
- 2001-10-05
- Regulation
- 890.5110
- Classification name
- Bath, Paraffin
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAMELA J FURMAN
- Address
- 1400 Sixteenth St., NW Suite 400 Washington DC US 20036 20036
FDA Registration Numbers#
- 1222304
- 2118418
- 3017930281
Source Documents#
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 |
| 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 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases