← Product Code [IMC](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC) · K013707 # SOFTIQUE, MODEL GI 11001 (K013707) _Global TV Concepts, Ltd. · IMC · Feb 1, 2002 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC/K013707 ## Device Facts - **Applicant:** Global TV Concepts, Ltd. - **Product Code:** [IMC](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC.md) - **Decision Date:** Feb 1, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.5110 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## 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 ## 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. ## Regulatory 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](/device/K001860.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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: info@globaltvconcepts.com 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 (954) 570-9999 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 {1}------------------------------------------------ KOI +c + p. 2/2 CONCEPTS LTD. 676 South Military Trai TV GLOBAL Deerfield Beach Florida 3344 Tel: 954.570.999: Tel. 06-151-000 Fax: 954.570.999 E-mail: info@globaltvconcepts.com 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 {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 (301) 597-1009 - 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 (800) 638-2041 or (301) 443-6597 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 {4}------------------------------------------------ ### 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 aaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa (Per 21 C.F.R. § 801.109) Mark N. Melkerson Division Sign-CA) Division of General. Restorative and Neurological Devices 510(k) Number -- K013707 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC/K013707](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMC/K013707) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com