(28 days)
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.
Not Found
This document is a marketing clearance letter from the FDA for the Windmere Model DS-2 Foot Bath (K980769). This type of document does not contain acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. This means that the device is deemed safe and effective for its intended use based on its similarity to previously cleared devices, rather than through a direct study demonstrating its performance against specific acceptance criteria.
The "Indications for Use" section (page 2) describes what the foot bath is intended for (Hydrotherapy; Professional footbath for a relaxing aqua massage, etc.) and lists contraindications, but these are not performance metrics or acceptance criteria for a study.
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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
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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
§ 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.