REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600

K013328 · Remington Products Company, LLC · IMC · Dec 3, 2001 · Physical Medicine

Device Facts

• Record ID: K013328
• Device Name: REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600
• Applicant: Remington Products Company, LLC
• Product Code: IMC · Physical Medicine
• Decision Date: Dec 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Useful for symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation. Relaxes muscles, relieves stiffness and muscle spasm. Stimulates circulation and for other conditions where heat is indicated.

Device Story

Remington Paraffin Spa (Models HS-250, PFS-600) is a heated paraffin wax bath for home use. Device consists of plastic enclosure, aluminum bucket, and internal heating assembly. User places hands or feet into melted wax to apply heat. Variable electronic heat control with timing circuit regulates wax temperature; settings (low, medium, high) and timing displayed on LCD. Operates on 120 Vac, 60 Hz household power. Provides therapeutic heat to relax muscles, relieve stiffness/spasms, and stimulate circulation for conditions like arthritis or bursitis.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Materials: plastic enclosure, aluminum bucket. Heating: internal assembly with variable electronic heat control and timing circuit. Display: LCD for temperature/timing. Power: 120 Vac, 60 Hz, 200 watts. Form factor: two sizes available.

Indications for Use

Indicated for patients requiring symptomatic relief of pain associated with arthritis, bursitis, and chronic joint inflammation; muscle relaxation; relief of stiffness and muscle spasms; and stimulation of circulation where heat therapy is indicated.

Regulatory Classification

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.

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.

Predicate Devices

• ParaSpaTM Paraffin Bath (K001860)

Submission Summary (Full Text)

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DEC 0 3 2001

REMINGTON REMINGTON PRODUC OMPANY L.L.C.

| Preparation Date: | October 5, 2001 |
|----------------------|-----------------------------------------------------|
| Contact Person: | Tim Simmone |
| | Senior Vice President and Chief Technical Officer |
| | Remington Products Company, L.L.C. |
| | 60 Main Street |
| | Bridgeport, Connecticut 06604 |
| | (T) [phone] |
| | (F) [phone] |
| Proprietary Name: | Remington® Paraffin Spa (Models HS-250 and PFS-600) |
| Common/Usual Name: | Paraffin Bath |
| Classification Name: | Paraffin Bath (per 21 C.F.R. § 890.5110) |

Classification: Class II

### Description:

The product covered by this 510(k) summary is a heated paraffin wax spa intended for home use. This product consists of a plastic enclosure, aluminum bucket and an internal heating assembly. The paraffin wax temperature is controlled by a variable electronic heat control with timing circuit. Temperature settings (low, medium, and high) and timing controls are displayed on a liquid crystal display. The product consumes 200 watts when plugged into a standard household electrical outlet supply of 120 Vac, 60 Hertz. The product comes in two different sizes.

### Intended Use:

- 1. Useful for symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation.
- Relaxes muscles, relieves stiffness and muscle spasm. 2.
- 3. Stimulates circulation and for other conditions where heat is indicated.

### Substantial Equivalence Claim:

The Remington Paraffin Spa® is substantially equivalent to the following legally marketed predicate device: ParaSpaTM Paraffin Bath by Homedics, Inc. (K001860).

Substantial equivalence is claimed because the Remington Paraffin Spa® and the HoMedics ParaSpa™ Paraffin Bath have the same intended use and very similar principles of operation and technological characteristics. Moreover, none of the minor technological differences between the two products raises any new questions of safety or effectiveness.

6-1

Tim Simmone Vice President and Chief Technical Officer

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Public Health Service

DEC 0 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Remington Products Company, L.L.C. c/o Ms. Pamela J. Furman Olsson, Frank and Weeda, P.C. 1400 Sixteenth Street, NW Suite 400 Washington, D.C. 20036-2220

Re: K013328

Trade/Device Name: Remington® Paraffin Spa (Models HS-250) and PFS-600) Regulation Number: 890.5110 Regulation Name: Paraffin Bath Regulatory Class: Class II Product Code: IMC Dated: October 5, 2001 Received: October 5, 2001

Dear Ms. Furman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) presidentially equivalent (for the indications felerenced above and nave acterimes ally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally many of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Device American Dev commerce print to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have occh recussion in quire approval of a premarket approval application (PMA). and Cosmetic rear (1101) that ao november to the general controls provisions of the Act. The Tou may, dicrorore, mainer of the Act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classinod (600 a00 ro) als. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advisou that I Drains on that your device complies with other requirements of the Act that I Drivias Intatutes and regulations administered by other Federal agencies. You must or any I cathates and the Act's requirements, including, but not limited to: registration and listing

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Page 2 - Ms. Pamela J. Furman

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Milliberson

Celia M. Witten, Ph.D., M.D. Director Divison of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K013328

# Collia U.S. Food and Drug Administration = Center for Devices and Radiological Health = 1

(Not yet assigned) 510(k) Number (if known):

Remington® Paraffin Spa Device Name:

Indications for Use:

- Useful in symptomatic relief of pain caused by arthritis, bursitis, and chronic joint . inflammation.
- Relaxes muscles, relieves stiffness and muscle spasm. .
- Stimulates circulation and for other conditions where heat is indicated. .

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