(68 days)
The AccuTread™ Shoe System is intended for use as a limb load monitoring device to assist in the rehabilitation of patients with insults to their lower extremities. The AccuTread™ Shoe System is intended to be used in any situation in which a therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.
Not Found
This document is a 510(k) clearance letter from the FDA for the AccuTread Shoe System. It does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It outlines regulatory requirements and contact information for further questions.
Therefore, I cannot provide a detailed response to your request, as the necessary information is not present in the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 23 1999
Ms. Cheryl G. Dyer Regulatory Compliance Specialist Chattanooga Group, Inc. Representing Orthopedic Technology Research, Inc. 4717 Adams Road, P.O. Box 489 Hixson, Tennessee 37343
K991313 Re: AccuTread Shoe System Trade Name: Regulatory Class: II Product Code: IRN Dated: April 14, 1999 April 16, 1999 Received:
Dear Ms. Dyer:
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 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 (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 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 regulation may result in regulatory In addition, FDA may publish further announcements action. 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 - Ms. Cheryl G. Dyer
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 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,
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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INDICATIONS
The AccuTread™ Shoe System is intended for use as a limb load monitoring device to The Acca Fread - Oneo Byoten. In inx rehabilitation of patients with insults to their lower montor immod werght bearing adming admission is intended to be used in any situation in which a therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.
(Division Sign-Off) Division of General Resto 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 890.5575 Powered external limb overload warning device.
(a)
Identification. A powered external limb overload warning device is a device intended for medical purposes to warn a patient of an overload or an underload in the amount of pressure placed on a leg.(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.