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K Number
K111279
Device Name
NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM
Manufacturer
ZYNEX MEDICAL, INC.
Date Cleared
2011-09-20

(138 days)

Product Code
IPF,GZJ,LIH
Regulation Number
890.5850
Type
Abbreviated
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Interferential Mode (IFC)

  • . Symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain.
    Neuromuscular Electrical Stimulation Mode (NMES)
  • . Muscle Re-education
  • . Prevention or Retardation of Disuse Atrophy
  • . Increasing Local Blood Circulation
  • . Maintaining or Increasing Range of Motion
  • . Relaxation of Muscle Spasms
    Transcutaneous Electrical Nerve Stimulation Mode (TENS)
  • . Management and Symptomatic Relief of Chronic Intractable Pain, Posttraumatic and Post-surgical Pain.
Device Description

Combination Neuromuscular Electrical Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator, Model NexWave.

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) letter for the Zynex Medical Combination Neuromuscular Electrical Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator, Model NexWave (K111279) does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a letter from the FDA to Zynex Medical, informing them that their device has been found substantially equivalent to legally marketed predicate devices. It outlines the regulatory classification, general controls provisions, and refers to the indications for use.

Crucially, it does not describe any specific performance study, clinical trial data, or detailed technical specifications related to the device's accuracy, efficacy metrics, or statistical results that would allow me to populate the requested table and answer the study-related questions. The letter focuses on the regulatory determination of substantial equivalence, not on a detailed performance evaluation report.

Therefore, I cannot provide the requested information based on the text provided.

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).