K6-I DIAGNOSTIC SYSTEM

K922456 · Myo-Tronics, Inc. · KZM · Jun 9, 1994 · Physical Medicine

Device Facts

• Record ID: K922456
• Device Name: K6-I DIAGNOSTIC SYSTEM
• Applicant: Myo-Tronics, Inc.
• Product Code: KZM · Physical Medicine
• Decision Date: Jun 9, 1994
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 890.1375
• Device Class: Class 2

Device Story

K6-1 Diagnostic System functions as diagnostic electromyograph; records electrical activity of muscles; used by clinicians to assess neuromuscular function; provides data for diagnostic evaluation of muscle activity; operates as clinical diagnostic tool.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Diagnostic electromyograph; Class II; Product Codes KZM and NFS; 21 CFR 890.1375.

Regulatory Classification

Identification

A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUN 8 - 2005

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Fray Adib

President

Myotronics-Noromed, Incorporated

15425 53rd Ave South

Tukwila, Washington 98188

Re: K922456

Trade/Device Name: K6-1 Diagnostic System

Regulation Number: 21 CFR 890.1375

Regulation Name: Diagnostic electromyograph

Regulatory Class: II

Product Code: KZM and NFS

Dated: December 23, 1992

Received: December 24, 1992

Dear Mr. Adib:

This letter corrects our substantially equivalent letter of April 15, 1994, 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 It (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. Please note: this response to your premarket notification submission

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Page 2 – Ms. Patterson

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

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