(189 days)
Diathermy Component. To generate deep heating within-body tissues for the treatment of conditions such as relief of pain, muscle spasms, and joint contractures.
Selicor Models A100 and D100
This document is a 510(k) premarket notification letter from the FDA to Selicor, Inc. regarding their Shortwave Diathermy Devices, Models A100 and D100. It confirms that the devices are substantially equivalent to legally marketed predicate devices.
This document does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. It is solely an FDA clearance letter. Therefore, I cannot provide the requested information based on the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird formed by a series of human profiles facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ·
JUL 3 0 2002
Selicor, Inc. C/O James B. Bingham Delta T Medical Consulting 515 Exeter #F7 San Antonio, Texas 78209
Re: K020227
Trade/Device Name: Selicor Models A100 and D100 Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Device Regulatory Class: Class II Product Code: IMJ Dated: May 21, 2002 Received: May 22, 2002
Dear Mr. Bingham:
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. James B. Bingham
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,
Sincerely yours,
Mark A Millmann
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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INDICATIONS FOR USE STATEMENT
Ver/ 3 - 4/24/96
Applicant: ___________________________________________________________________________________________________________________________________________________________________ Selicor, Inc. KO20227 510(k) Number (if known):_ tenovat
Device Name: Selicor A100; DIOO
Indications for Use:
Diathermy Component. To generate deep heating within-body tissues for the treatment of conditions such as relief of pain, muscle spasms, and joint contractures.
Concurrence of CDRH, Office of Device Evaluation (OD)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Mark A. Millmann
f General, Restorative and Neurological Devices
20227 510(k) Number
N/A