(112 days)
The BACK - ON - TRAC is intended for the treatment of acute and chronic low back pain of disc origin or due to malalignments of the apophyseal joints.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "BACK-ON-TRAC". It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, device performance, or specific studies conducted.
Therefore, I cannot provide the requested information. The letter only confirms that the device can be marketed based on its substantial equivalence to pre-existing devices, but it does not detail the technical performance or the studies used to demonstrate that performance.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract shapes that resemble a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 1999
Mr. David A. Sciortino President BACK-ON-TRAC, Inc. 344 Clarendon Saint Charles, Missouri 63301
K984190 Re: BACK-ON-TRAC Trade Name: Regulatory Class: I HST Product Code: February 16, 1999 Dated: February 16, 1999 Received:
Dear Mr. Sciortino:
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 (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 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 against 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 Regulations, 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 Regulation (QS) for Medical Devices: General requlation (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 regulation 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 regulations.
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Page 2 - Mr. David A. Sciortino
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 device and thus, permits your device to proceed to the market.
If you desire specific advice for your device 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 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,
Celia M. Whitten, 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
Enclosure
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K984190/S,
Image /page/2/Picture/1 description: This image contains information about a medical device. The 510(k) number, if known, is K984190. The device name is BACK-ON-TRAC, and there is a section for indications for use, but it is blank in this image.
The BACK - ON - TRAC is intended for the treatment of acute and chronic low back pain of disc origin or due to malalignments of the apophyseal joints.
Contraindications for the BACK - ON - TRAC include:
- a: Neoplasm's
- b: Fractures
- c: Tuberculosis / Potts Disease
- d: All infective or inflammatory disease of the vertebra.
- e: Cardiac or circulatory disease and respiratory problems.
- f: Pregnancy after the fourth month.
- g: Contusions and stretching injuries of the lower back.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (C
(Division Sign-Off)
Division of General Restorative Devices K904190
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 888.5850 Nonpowered orthopedic traction apparatus and accessories.
(a)
Identification. A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.