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K Number
K032653
Device Name
E275
Manufacturer
MICRO CURRENT TECHNOLOGY, INC.
Date Cleared
2003-09-12

(15 days)

Product Code
GZJ
Regulation Number
882.5890
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

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:

  1. Acceptance criteria and reported device performance: This document only states the device's indications for use.
  2. Sample size and data provenance for the test set: Not mentioned.
  3. Number of experts and qualifications for ground truth: Not mentioned.
  4. Adjudication method: Not mentioned.
  5. MRMC comparative effectiveness study: No information on a comparative effectiveness study, with or without AI assistance, is provided.
  6. Standalone performance study: No details about a standalone performance study are present.
  7. Type of ground truth used: Not mentioned.
  8. Sample size for the training set: Not mentioned as there's no mention of a training set or an AI component.
  9. 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.

§ 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).