(31 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology. The intended use and device description (though not found) do not suggest the use of such technologies.
Yes
The device is described as providing symptomatic relief for pain, relaxing muscles, relieving stiffness and muscle spasms, and stimulating circulation, all of which are therapeutic effects.
No
The device's intended use is for symptomatic relief of pain, muscle relaxation, and circulation stimulation, not for diagnosing conditions.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as providing symptomatic relief for pain, relaxing muscles, relieving stiffness, stimulating circulation, and for conditions where heat is indicated. These are all therapeutic or physical effects on the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens.
The intended use points towards a device that applies some form of energy or therapy to the body, likely a physical therapy device or a heat therapy device.
N/A
Intended Use / Indications for Use
Useful in symptomatic relief of pain caused by medically diagnosed 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
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joe Elrod Director of Regulatory Affairs Chattanooga Group, Inc. 4717 Adams Road P.O. Box 489 37343 Hixson, Tennessee
MAR 2 7 1998
Re: K980718 Para-Care® Regulatory Class: II Product Code: IMC February 18, 1998 Dated: Received: February 24, 1998
Dear Mr. Elrod:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗ್ಗ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Joe Elrod
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to ene regulation chercred) hisbidiang by Sother general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
Useful in symptomatic relief of pain caused by medically diagnosed arthritis, bursitis, and chronic joint inflammation.
Relaxes muscles, relieves stiffness and muscle spasm.
Stimulates circulation and for other conditions where heat is indicated.
Preseription Use (Per 21 CFR 801.109)
signature
(Division Sig Division of 2980718 510(k) Num