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DYNA T-2000 Physical Therapy System
This document is a 510(k) clearance letter from the FDA for a device called the DYNA T-2000 Physical Therapy System. It states that the device is substantially equivalent to legally marketed predicate devices.
However, this letter does not contain the information required to answer your questions about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of information is typically found in the 510(k) submission itself, often in sections detailing performance data and clinical studies, which are not part of this clearance letter.
Therefore, I cannot provide the requested details based solely on the provided text.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steven J. Daffer ·President Thermia, Inc. 9220 James Avenue South Bloomington, Minnesota 55431
NOV - 3 1997
Re: K955808 DYNA T-2000 Physical Therapy System Requlatory Class: II Product Codes: IMB and IRO Dated: August 6, 1997 Received: August 7, 1997
Dear Mr. Daffer:
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 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 aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements 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 requlations.
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Page 2 - Mr. Steven J. Daffer
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 markets preams, 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,
to colle
C. Colin M. Witton, Ph.D. M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
§ 890.5250 Moist steam cabinet.
(a)
Identification. A moist steam cabinet is a device intended for medical purposes that delivers a flow of heated, moisturized air to a patient in an enclosed unit. It is used to treat arthritis and fibrosis (a formation of fibrosis tissue) and to increase local blood flow.(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.