JE 2000

K993878 · Jack'S Electrodes · IKN · Feb 1, 2000 · Physical Medicine

Device Facts

• Record ID: K993878
• Device Name: JE 2000
• Applicant: Jack'S Electrodes
• Product Code: IKN · Physical Medicine
• Decision Date: Feb 1, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1375
• Device Class: Class 2

Intended Use

The electromyograph is intended to be used by a licensed practitioner, for the purpose of diagnostic neurological procedures.

Device Story

JE2000 Electromyograph; device used by licensed practitioners for diagnostic neurological procedures. Input: electrical signals from muscles/nerves. Output: electromyographic data for clinical assessment of neurological function. Used in clinical settings to assist in diagnosis of neuromuscular conditions.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device classification and intended use.

Technological Characteristics

Electromyograph device; Class II; Product Code GWP. Technical specifications not detailed in provided documentation.

Indications for Use

Indicated for use by licensed practitioners for diagnostic neurological procedures.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2000

Mr. Antony R. H. Fender Official FDA Correspondent Jack's Electrodes 2227 East Crescent Drive Altadena, California 91001

Re: K993878 Trade Name: JE2000 Electromyograph Regulatory Class: II Product Code: GWP Dated: October 27, 1999 Received: November 15, 1999

Dear Mr. Fender:

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 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.

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.

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Page 2 - Mr. Antony R. H. Fender

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]. 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,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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510(k) Number (if known): K99389 F

JE2000 Device Name

The electromyograph is intended to be used by a licensed Indications For Use: practitioner, for the purpose of diagnostic neurological procedures.

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Concurrance of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use _ (Per 21 CFR 801.109) Over-The-Counter Use _

Htyt Rludle

(Optional Format 1-2-96)

(Division Sign-Off) (Division Olgh Similar)
Division of General Restorative Devi K993898 510(k) Number 8

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