(85 days)
Not Found
No
The device description and intended use focus solely on the physical components and function of a paraffin bath for heat therapy, with no mention of AI or ML capabilities.
Yes
The Intended Use/Indications for Use section explicitly states that the device is "Useful in symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation," "Relaxes muscles, relieves stiffness and muscle spasm," and "Stimulates circulation." These are therapeutic claims.
No
The device is intended for symptomatic relief of pain, muscle relaxation, and circulation stimulation, not for diagnosing medical conditions.
No
The device description clearly outlines a physical hardware device (paraffin bath) with heating elements, power cord, lid, wax, and liners. It is not software-only.
Based on the provided information, the Softique™ Paraffin Bath is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended uses listed are for symptomatic relief of pain, muscle relaxation, and stimulating circulation. These are therapeutic applications, not diagnostic tests performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is a physical bath designed to heat paraffin wax for external application to the body. It does not involve any analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Softique™ Paraffin Bath does not fit this definition.
N/A
Intended Use / Indications for 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 joint inflammation
- Relaxes muscles, relieves stiffness and muscle spasm
- Stimulates circulation and for other conditions where heat is indicated
Product codes
IMC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5110 Paraffin bath.
(a)
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.(b)
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.
0
FEB 01 2002
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
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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.
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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
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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 --