T-GUARD

K945537 · Med ET AL Development · LQX · Mar 23, 1995 · Physical Medicine

Device Facts

• Record ID: K945537
• Device Name: T-GUARD
• Applicant: Med ET AL Development
• Product Code: LQX · Physical Medicine
• Decision Date: Mar 23, 1995
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3475
• Device Class: Class 1

Device Story

T-Guard is a limb orthosis; device provides structural support or stabilization to a limb; intended for use in clinical or home settings; operated by patients or healthcare providers; mechanical design provides physical support to affected limb; assists in patient mobility or rehabilitation; device does not involve electronic processing or software.

Clinical Evidence

No clinical data provided; device is a Class I limb orthosis.

Technological Characteristics

Limb orthosis; mechanical support structure; materials and specifications not detailed in provided documentation; no electronic components or software; non-powered.

Regulatory Classification

Identification

A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

MAY 2 5 2005

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Eugene Zilber
Med et al Development
815 Tadlock Place
Matthews, North Carolina 28105

Re: K945537

Trade/Device Name: T-Guard
Regulation Number: 21 CFR 890.3475
Regulation Name: Limb Orthosis
Regulatory Class: I
Product Code: LQX
Dated: February 14, 1995
Received: February 21, 1995

Dear Mr. Zilber:

This letter corrects our substantially equivalent letter of March 23, 1995, regarding the classification of your device which was incorrectly identified as "unclassified."

We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.

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Page 2 – Mr. Eugene Zilber

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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. An 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, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone].

Sincerely yours,

Chiu S. Lin, PhD

Director

Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and
Radiological Health