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K Number
K171387
Device Name
EMS100 Tri-Wave Combination Stimulator
Manufacturer
Elite Medical Supply of New York, LLC
Date Cleared
2017-05-31

(20 days)

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

Interferential Current Mode: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post surgical and post traumatic pain.

Neuromuscular Stimulator Mode: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding disuse atrophy, muscle re-education, and immediate post surgical stimulation of calf muscles to prevent venous thrombosis.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "EMS100 Tri-Wave Combination Stimulator." It is not a study report or clinical trial documentation, and therefore, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance.

Specifically, this document only confirms that the device is substantially equivalent to legally marketed predicate devices. It does not provide:

  • A table of acceptance criteria and reported device performance.
  • Details about sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a specific study.
  • Information about training sets.

The only relevant information that could be derived from this letter is:

  • Device Name: EMS100 Tri-Wave Combination Stimulator
  • Indications for Use:
    • Interferential Current Mode: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
    • Neuromuscular Stimulator Mode: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding disuse atrophy, muscle re-education, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
  • Regulatory Class: Class II
  • Product Code: IPF, LIH

To answer your prompt, you would need to access the premarket notification (510(k) submission) itself, which would contain the performance data and testing methodology used to demonstrate substantial equivalence. This public letter only states the FDA's determination.

§ 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).