E275 by MICRO CURRENT TECHNOLOGY, INC.

The E275 is a dual channel device that produces constant micro ampere currents with the selected envelopes, waveforms; frequencies, and polarity, with a maximum voltage of 30 volts.

AI/ML Overview

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter and an "Indications For Use" statement. It does not contain information about:

Acceptance criteria and reported device performance: This document only states the device's indications for use.
Sample size and data provenance for the test set: Not mentioned.
Number of experts and qualifications for ground truth: Not mentioned.
Adjudication method: Not mentioned.
MRMC comparative effectiveness study: No information on a comparative effectiveness study, with or without AI assistance, is provided.
Standalone performance study: No details about a standalone performance study are present.
Type of ground truth used: Not mentioned.
Sample size for the training set: Not mentioned as there's no mention of a training set or an AI component.
How ground truth for the training set was established: Not mentioned.

The document primarily focuses on the FDA's determination of substantial equivalence for the E275 Transcutaneous Electrical Nerve Stimulator (TENS) device to a legally marketed predicate device. It confirms the device's regulatory classification and allows it to be marketed. It does not include the detailed technical study results or acceptance criteria that would typically be found in a design validation report or a clinical study report.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2003

Micro Current Technology, Inc. c/o Mr. Marc M. Mouser Project Engineer/Program Reviewer Underwriters Laboratories, Inc. 2600 NW Lake Road Camas, Washington 98607

Re: K032653

Trade/Device Name: E275 Transcutaneous Electrical Nerve Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: August 27, 2003 Received: August 28, 2003

Dear Mr. Mouser:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Marc M. Mouser

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

iriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment Ib

Page 1 of 1

510(k) Number (if known):	K032653
Device Name:	E275 TENS

Indications For Use:

The E275 Transcutaneous Electrical Nerve Stimulator (TENS) device is intended to by used by physicians or licensed practitioners for symptomatic relief of chronic intractable pain by sending electrical impulses through the skin to the nerves lying directly beneath the skin surface. These impulses help to block the body's ability to send a pain message to the brain, thereby reducing the pain sensation. The E275 is a dual channel device that produces constant micro ampere currents with the selected envelopes, waveforms; frequencies, and polarity, with a maximum voltage of 30 volts.

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K032653

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).