SOFTIQUE, MODEL GI 11001

K013707 · Global TV Concepts, Ltd. · IMC · Feb 1, 2002 · Physical Medicine

Device Facts

• Record ID: K013707
• Device Name: SOFTIQUE, MODEL GI 11001
• Applicant: Global TV Concepts, Ltd.
• Product Code: IMC · Physical Medicine
• Decision Date: Feb 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5110
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

Softique™ Paraffin Bath is an over-the-counter device for heat therapy. It consists of a basin holding up to five pounds of paraffin wax. The device uses two internal heaters (90 W total) to melt wax and maintain a temperature range of 123-130°F. Operated by the user at home, the device is used by immersing body parts into the melted wax. The heat application is intended to provide symptomatic relief for arthritis, bursitis, and joint inflammation, as well as to relax muscles and stimulate circulation. The unit includes a power cord, plastic lid, three pounds of hypo-allergenic paraffin wax, and 60 plastic liners.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Full-size paraffin bath; 90 W dual-heater system; 123-130°F operating temperature; 120 V, 60 Hz power input. Includes plastic lid and liners. No complex software or electronic sensing/actuation algorithms.

Indications for Use

Indicated for individuals seeking symptomatic relief of pain from arthritis, bursitis, and chronic joint inflammation; muscle relaxation; relief of stiffness and muscle spasms; and stimulation of circulation.

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

• ParaSpa™ (PAR-200) Paraffin Bath by Homedics
• Therabath® by W.R. Medical Electronics Co. (K001860)

Submission Summary (Full Text)

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FEB 01 2002

K013707

GLOBAL TV CONCEPTS LTD. 676 South Military Tra

Deerfield Beach Florida 3344 Tel: 954.570.999: Fax: 954.570.999 E-mail: [e-mail] Website: www.globaltvconcepts.com

#### ATTACHMENT 6

### 510(k) Summary

## (As required by 21 C.F.R. § § 807.87(h), 807.92)

Date of Submission

November 8, 2001

Identification of Applicant Applicant

Global TV Concepts, Ltd. 676 South Military Trail Deerfield Beach, Florida 33442

Contact Person

Laurie Braden President [phone]

Trade or Proprietary Name

Common Name Classification Name Classification

Softique™ Paraffin Bath GI-111001 Paraffin Bath Paraffin Bath II

#### Intended Use

The Softique™ Paraffin Bath is an over-the-counter device intended for the following uses:

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

We bring Success
through
Innovation

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CONCEPTS LTD. 676 South Military Trai TV GLOBAL

Deerfield Beach

Florida 3344 Tel: 954.570.999:

Tel. [phone]

Fax: 954.570.999

E-mail: [e-mail]

Website: www.globaltvconcepts.con

#### Device Description

The Softique™ Paraffin Bath is a full-size paraffin bath with a paraffin wax capacity of five pounds (with a recommended use of three to four pounds of paratin wax), a melting time for the paraffin wax of approximately five hours, and a temperature range for the paraffin wax of 123-130°F. The unit utilizes two heaters with a total of 90 W in order to melt and maintain the temperature of the melted paraffin wax. The unit has an operation voltage of 120 V, 60 Hz. The Softique™ Paraffin Bath is supplied with a power cord, a plastic lid, three pounds of pure, hypo-allergenic paraffin wax, and 60 plastic liners.

### Substantial Equivalence

The Softique™ Paraffin Bath is substantially equivalent to the following models of paraffin baths currently in commercial distribution:

- ParaSpa™ (PAR-200) Paraffin Bath by Homedics 1.
- Therabath® by W.R. Medical Electronics Co. 2.

K001860 pre-amendment device

### Technological Characteristics

Substantial equivalence is claimed because intended uses, directions for use, technology, and operating principles are the same for all three devices. Technical differences do not affect the safety or efficacy of the product. Other differences between the devices are cosmetic in nature.

We bring Success
through
Innovation

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Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of a stylized caduceus with three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 0 1 2002

Ms. Laurie Braden President Global TV Concepts, LTD 676 South Military Trail Deerfield Beach, Florida 33442

Re: K013707

Trade/Device Name: Softique Paraffin Bath Regulation Number: 21 CFR 890.5110 Regulation Name: Paraffin Bath Regulatory Class: II Product Code: IMC Dated: November 8, 2001 Received: November 8, 2001

Dear Ms. Braden:

We have reviewed your Section 510(k) premarket notification of intent to market the indication in we nave leviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regard) the enactment date of the Medical Device Artock Ford Drug commence prior to may 20, 1976, the exactions of the provisions of the Federal Food. Drug, devices mail have been rechasined in asses approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosment Act (Act) that to not require to the general controls provisions of the Act. The I ou may, mercrore, manel the Act include requirements for annual registration, listing of general controls provisions of the recor 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 classified (500 abor of als. Existing major regulations affecting your device can may be subject to such acareered esgulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Goas of I sants concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least of advised that I Drivised as a sour device complies with other requirements of the Act that I DIT has made a avad regulations administered by other Federal agencies. You must or any I collar statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the rice 3 requirements, the submanufacturing practice requirements as set CFR Part 6077, laboring (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Laurie Braden

This letter will allow you to begin marketing your device as described in your Section 510(k) This icher with anow you to oegin maing of substantial equivalence of your device to a legally prematication. "The PDF interior simmily sification 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 II you desire specific arrice for your witto diagnostic devices), please contact the Office of additionally 21 CHT Par 05710 for his nally, for questions on the promotion and advertising of Compliance at [phone] - 12-28 - 12-2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - - - - - - - - - - - - - - - your de roo, products "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 Other general 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 Milken

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

Enclosure

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### ATTACHMENT 8

### INDICATIONS FOR USE STATEMENT

Page 1 of 1

| 510(k) Number: | K013707 |
|----------------|-------------------------|
| Device Name: | Softique™ Paraffin Bath |

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-the-Counter Use

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(Per 21 C.F.R. § 801.109)

Mark N. Melkerson

Division Sign-CA) Division of General. Restorative and Neurological Devices

510(k) Number --

K013707