VMT SYSTEM

K971549 · Target Health, Inc. · LXV · Oct 5, 1998 · EN

Device Facts

• Record ID: K971549
• Device Name: VMT SYSTEM
• Applicant: Target Health, Inc.
• Product Code: LXV · EN
• Decision Date: Oct 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

The VMT™ System is designed for the evaluation of visuo-motor performance disturbances.

Device Story

VMT™ System (Ataxiagraph) evaluates visuo-motor performance disturbances. Device functions as diagnostic tool for assessing patient balance and motor control. Operates by measuring postural sway or motor response patterns; data processed to quantify visuo-motor performance. Used in clinical settings by healthcare professionals to assist in diagnosing or monitoring balance-related conditions. Output provides objective metrics of motor stability, aiding clinicians in evaluating patient status and determining appropriate therapeutic interventions. Benefits include standardized assessment of motor performance compared to subjective observation.

Clinical Evidence

Clinical studies were performed to evaluate the device. Results concluded the device is safe and effective for its intended use.

Technological Characteristics

Ataxiagraph system for visuo-motor performance evaluation. Device utilizes sensors to monitor postural or motor stability. Technical specifications and materials are not detailed in the provided documentation. System is intended for clinical use.

Indications for Use

Indicated for the evaluation of visuo-motor performance disturbances in patients requiring clinical assessment of balance and motor control.

Predicate Devices

• Equitest System (K851744)
• Pro & Smart Balance Master Systems (K946229)

Submission Summary (Full Text)

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K971549.

G.N.P. Holdings LTD 37 Shvedia St., Danya, Haifa-Israel

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VMT™ System -Ataxiagraph 510(k) Premarket Notification Dated: April 3, 1997

#### 12. 510(k) Summary

# THE VMT™ SYSTEM FOR THE EVALUATION OF VISUO-MOTOR PERFORMANCE

Contact: Target Health, Inc. 310 Madison Avenue, 22nd Floor New York, NY 10017

Tel: [phone] Fax: [phone]

Sponsor: Taly Hocherman G.N.P. Holdings LTD 37 Shvedia Street, Danya, Haifa-Israel

Tel: ++972-4-8262293/4 Fax: ++972-4-8242088

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#### 12.1 Device Name

The VMT™ System is provided as follows:

- Trade Name VMT™ System a.
- b. Common and Descriptive Name - Ataxiagraph

12.2 Predicate Devices/ Company Names and Addresses

The predicate devices are listed below with their 510(K) clearance numbers.

The Equitest System - (K851744) NuroCom International, Inc. 9570 SE Lawnfield Road, Clackamas, Oregon 97015-96 USA

The Pro & Smart Balance Master Systems - (K946229) NeuroCom International, Inc. 9570 SE Lawnfield Road, Clackamas, Oregon 97015-96 USA

### 12.3 Clinical Experience

Clinical studies have been performed and have concluded that the device was safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird figure. The text is in all capital letters.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 1698

Jules T. Mitchel, M.D. President Target Health, Inc. 310 Madison Avenue 22nd Floor New York, New York 10017

K971549/S004 Re : Trade Name: VMT System Regulatory Class: Unclassified Product Code: LXV Dated: July 23, 1998 Received: July 24, 1998

Dear Dr. Mitchel:

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. ಕ 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 - Dr. Jules T. Mitchel

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M

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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VMT™ System -Ataxiagraph 510(k) Premarket Notification Dated: April 3, 1997

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## 8. Indication for use

The VMT™ System is designed for the evaluation of visuo-motor performance disturbances.

Prescription Use
(Per 21 CFR 801.109)

ារ តាម

ses

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971549

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