(115 days)
- RELIEVES MINOR MUSCLE ACHES AND PAINS
- DRY HEAT THERAPY FOR BODY SURFACES
Not Found
The provided document is a 510(k) premarket notification response from the FDA regarding two infrared massagers (Models KM-213H and KM-201) manufactured by Windmere Corporation. This type of document declares substantial equivalence to previously marketed devices and permits the devices to be marketed, subject to general controls.
Therefore, this document does not contain any information about acceptance criteria or supporting studies because it is a regulatory clearance letter, not a device performance report or clinical study summary.
Specifically:
- It does not list any acceptance criteria for device performance.
- It does not describe any study conducted to prove the devices meet such criteria.
- It does not include any of the detailed information requested in the prompt, such as sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This means the determination is based on the devices being similar enough to existing devices, not on new performance studies against specific acceptance criteria for these particular models.
The "Enclosures" mentioned in the letter might contain the indications for use and potentially documentation from Windmere Corporation's 510(k) submission, which could include performance data if it was relevant for comparison to a predicate device. However, this specific letter does not provide that information.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, with three lines representing the staff and two intertwined snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Windmere Corporation JUN 1 3 1997 c/o Mr. Richard C. Lanzillotto Vice President North American Technical Services Corporation 30 Northport Road Sound Beach, New York 11789-1734
Re : K970590 Health Zone/Healthy Vibes Mini Rechargeable Infrared Massager, Model KM-213H K970592 Health Zone/Healthy Vibes Infrared Massager Set, Model KM-201 Regulatory Class: II Product Codes: ILY and ISA Dated: April 29, 1997 Received: May 5, 1997
Dear Mr. Lanzillotto:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are 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 devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your
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Page 2 - Mr. Richard C. Lanzillotto
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.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling requlation (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 devices, 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,
Celia M. Witten, Ph.D., M.D.
Ph.D., M.D. Celia M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and ' Radiological Health
Enclosures
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K470592/A²
NATS Cor
North American Technical Services Corp. 0 Northport Road
und Beach, New York 11789-1734
Tel: 516-744-0059
Fax: 516-744-0192
Engineering, Regulatory and Consulting Services Product and Process Management
REF
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510K K970592 WINDMERE MODEL KM-201 :
IN KEEPING WITH OUR CONVERSATION, ALL CLAIMS WILL BE DELETED EXCEPT AS FOLLOWS:
- -RELIEVES MINOR MUSCLE ACHES AND PAINS
-DRY HEAT THERAPY FOR BODY SURFACES
Over-the-Counter Use X
signature
(Division Sion-Off Division of General 510(k) Number
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.