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EMG Recording Ring Electrode
The provided text is a letter from the FDA to Chalgren Enterprises, Inc. regarding a 510(k) notification for an EMG Recording Ring Electrode. It states that the device is substantially equivalent to legally marketed devices.
This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. Therefore, I am unable to provide the requested details based on the input.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Sarvice
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 1996
RE
Richard Kaiser, CEO Chalgren Enterprises, Inc. 8021 Carmel Street Gilroy, California 95020
Re: K953356 EMG Recording Ring Electrode Regulatory Cass: II (two) Product Code: 84 GXY Dated: October 16, 1995 October 23, 1995 Received:
Dear Mr. Kaiser:
We have reviewed your Section 510(k) notification in market the device We have reviewed your section 510(K) notreaded is subscantlally couivalent 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 You may, therefore, market the device, subject to the general controls (Act). The general controls provisions of the Act include provisions of the Act. provisions of the net. The gencian, listing of devices, good manufacturing requirements for annual registions 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. of class fly (regulations affecting your device can be found in the Code of Exting major regulacions arres 800 to 895. A subscanting Breachice for Medical determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic Devices: General (onr) regulacion (rug Administration (FDA) will regulatory Failure to comply with the GMP regulation may result in regulatory assumptions. In addition, FDA may publish further announcements concerning your action. accion. In addiction, Rogister. Please note: this response to your premarke notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Sections 531 childing one or other Federal Laws or Regulations.
This letter will immediately allow you to begin marketing your device as Ints Tecter will premarket notification. An PDA finding of substantial equivalence of your device to a legally marketed predicated to the market equivalence on your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, your may not but it does not mean that for approved your its labeling as being georged by If you desire specific advice for your device on our labeling regulation EDA . (21 CFR Part 801 and additionally 809.10 for in xi consideres , reconcion and (2) CFR Part 801 and adolerone ontact the Office of Compliance, Promotion and promotion, of advertising prease and 301) 594-4639. Other general information
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. j ... .. .pomaro.clicles ander the hel may be vinding the Olvision of Small . . Juli :: sponstorers and their coll free number (800) 638-2041 or at (301) 443.6597.
Sincerely yours.
Thomas J. Carlin
Thomas J. Calimhan, Ph.D. Acting Director Division of Cardiovascular. Rospiracory, and Neurological Devices Office of Device Evaluation Cencer for Devices and Radiological Health
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§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).