(309 days)
The UltraStim Kit is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "UltraStim Kit." It confirms the device's substantial equivalence to predicate devices for its intended use. This type of document does not contain the detailed acceptance criteria or the study that proves the device meets those criteria.
Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance results) from this document. This letter is a regulatory approval notice, not a study report.
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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 a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 28 2003
Dan Jeffery Axelgaard Mfg. Co., Ltd. 1667 S. Mission Road Fallbrook, California 92028-4115
Re: K013532
Trade/Device Name: UltraStim Kit Regulation Number: 21 CFR 882.5890, 21 CFR 882.1320 and 21 CFR 890.3490 Regulation Name: Transcutaneous Electrical Nerve Stimulator, Cutaneous Electrode and Truncal Orthosis
Regulatory Class: Class II Product Code: GZJ, GXY and IQE Dated: May 28, 2002 Received: June 6, 2002
Dear Mr. Jeffery:
This letter corrects our substantially equivalent letter of August 22, 2002 to clarify the over-the-counter (OTC) status of your device.
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 (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 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.
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Page 2 - Mr. Dan Jeffery
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.
This letter will allow you to continue 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark H. Mulkusa
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
510(k) Number (if known): K013532
Device Name: UltraStim Kit
Indications for Use:
The UltraStim Kit is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-the-Counter (OTC) Use
l. Mark N. Millman
al, Restorative
510(k) N
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).