(482 days)
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- To temporarily increase local blood circulation.
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- To temporarily reduce minor muscular pain.
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- To help induce relaxation of muscles.
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- To treat arthritis and fibrosis.
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- To provide topical heating.
Not Found
I am sorry, but based on the provided document, I cannot answer the request as the document does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) clearance letter for the DermaMED System, which states that the device is substantially equivalent to legally marketed predicate devices and lists its indications for use. It does not include details on specific device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.
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APR 1 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Scandia Manufacturing Ltd. C/O Ronald Berglund, General Counsel Sybaritic, Inc. 9220 James Avenue South Minneapolis, MN 55431
Re: K003916
Trade/Device Name: DermaMED System Regulation Number: 21 CFR 890.5250 Regulation Name: Moist Steam Cabinet Regulatory Class: Class II Product Code: IMB Dated: January 28, 2002 Received: February 19, 2002
Dear Mr. Berglund:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Ron Berglund
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Miller
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER: K003916
DEVICE NAME: DermaMED™ System
INDICATIONS FOR USE:
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- To temporarily increase local blood circulation.
-
- To temporarily reduce minor muscular pain.
-
- To help induce relaxation of muscles.
-
- To treat arthritis and fibrosis.
-
- To provide topical heating.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use -------(Optional Format)
Mark N Milkersen
K003916
(Division Sign-Off) (Division of General, Restorative and Neurological Devices KOO3916
510(k) Number_
§ 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.