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Health Zone/Healthy Vibes Mini Rechargeable Infrared Massager, Model KM-213H; Health Zone/Healthy Vibes Infrared Massager Set, Model KM-201
This FDA 510(k) letter for the Health Zone/Healthy Vibes Mini Rechargeable Infrared Massager and Infrared Massager Set (models KM-213H and KM-201, respectively) does not contain the information requested about acceptance criteria or a study proving the device meets said criteria.
The letter is primarily a declaration of substantial equivalence to previously marketed predicate devices, which allows the manufacturer to market the new devices. It confirms that the devices are regulatory Class II and are subject to general controls.
Therefore, I cannot provide the detailed information requested in the prompt based on this document. The document primarily focuses on regulatory approval based on equivalence, not on specific performance metrics or studies.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
REC 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 May 5, 1997 Received:
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 You may, of the Federal Food, Drug, and Cosmetic Act (Act). 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 vour 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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and ' Radiological Health
Enclosures
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K1 10540/A2
NATS Cor
North American Technical Services Corp. `0 Northport Road rund Beach, New York 11789-1734
Tel: 516-744-0059
:
Fax: 516-744-0192
Engineering, Regulatory and Consulting Services Product and Process Management
REF 510K K970590 WINDMERE MODEL KM-213H :
IN KEEPING WITH OUR CONVERSATION, ALL CLAIMS WILL BE DELETED E AS FOLLOWS :
- RELIEVES MINOR MUSCLE ACHES AND PAINS ー
DRY HEAT THERAPY FOR BODY SURFACES -
Over-the-Counter Use X
10/11903
Sign-Off f General Re
§ 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.