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K Number
K974585
Device Name
IF-727 INTERFERENTIAL STIMULATOR
Manufacturer
SKYLARK DEVICE CO., LTD.
Date Cleared
1998-03-06

(88 days)

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

ARE USED FOR THE SYMPTOMATIC RELIEF AND MANAGEMENT OF CHRONIC (LONG TERM) INTRACTABLE PAIN AND AS AN ADJUNCTIVE TREATMENT IN THE MANAGEMENT OF POST SURGICAL AND POST TRAUMATIC ACUTE PAIN PROBLEMS.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the IF-727 Interferential Stimulator. It does not contain information about acceptance criteria, device performance studies, or clinical trial methodology.

Therefore, I cannot provide the requested information, including:

  1. A table of acceptance criteria and reported device performance
  2. Sample size used for the test set and data provenance
  3. Number of experts used to establish ground truth and their qualifications
  4. Adjudication method
  5. MRMC comparative effectiveness study results
  6. Standalone performance
  7. Type of ground truth used
  8. Sample size for the training set
  9. How ground truth for the training set was established

This letter only states that the device is substantially equivalent to legally marketed predicate devices for the indicated uses, which are for symptomatic relief and management of chronic pain, and as an adjunctive treatment for post-surgical and post-traumatic acute pain.

§ 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).