(28 days)
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Not Found
No
The summary describes a simple hydrotherapy device for foot massage and pedicure preparation, with no mention of AI, ML, image processing, or data analysis typically associated with such technologies.
No
Explanation: The device is described as a professional footbath for relaxation and pedicure preparation, providing comfort and soothing relief, which are not therapeutic claims.
No
Explanation: The device is described as a "footbath for a relaxing aqua massage" for "pedicure preparation" and "soothing relief for tired feet." There is no indication that it is used to diagnose any medical condition.
No
The device is described as a "Professional footbath," which is a physical hardware device. The description of its function ("relaxing aqua massage," "massages soles of feet") further confirms it is a hardware device that uses water and potentially mechanical action. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for hydrotherapy, foot massage, and pedicure preparation. This is a physical therapy/comfort application, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.
- Anatomical Site: The device acts on the feet externally, not by analyzing internal biological samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This footbath does not fit that description.
N/A
Intended Use / Indications for Use
Hydrotherapy; Professional footbath for a relaxing aqua massage. Ideal for pedicure preparation. Gently massages soles of feet, comforts soles of feet, soothing relief for tired feet.
Product codes
ILJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Feet
Indicated Patient Age Range
Not for children, elderly or handicapped unless supervised.
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 890.5100 Immersion hydrobath.
(a)
Identification. An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.(b)
Classification. Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, 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 & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 27 1998
Mr. Richard C. Lanzillotto Agent for Windmere Corporation North American Technical Services Corporation 30 Northport Road Sound Beach, New York 11789-1734
Re: K980769 Windmere Model DS-2 Foot Bath Regulatory Class: II Product Code: ILJ Dated: February 25, 1998 Received: February 27, 1998
Dear Mr. Lanzillotto:
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 The general controls provisions of the Act 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. ਸੀ 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 requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 requlations.
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Page 2 - Mr. Richard C. Lanzillotto
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 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other 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,
C. Colla M. Witton, Ph.D.
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Windmere Products 510K Notification Foot Bath Model DS-2
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Windmere DS-2
Indications for Use: Hydrotherapy; Professional footbath for a relaxing aqua massage. Ideal for pedicure preparation. Gently massages soles of feet, comforts soles of feet, soothing relief for tired feet.
Contraindications:
- Anyone suffering from leg or foot problems, e.g. phlebitis, varicose veins, a rash, open sores or other ailments, should first consult a doctor before use.
- Do not stand in the appliance. Use only in a sitting position.
- Consult your physician if you have any therapeutic questions regarding its use.
- Do not use on any unexplained pain before consulting your physician. ﮯ
- Consult your physician before using the aqua massager if you are pregnant, diabetic or ill.
- Do not use the aqua massager on any area of the body that is swollen, burned, or inflamed.
- Do not use continuously for more than 20 minutes.
- Not for children, elderly or handicapped unless supervised.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K980769
Over-The-Counter Use
Prescription Use (Per 21 CFR 801.109)
NATS Corp.
OR