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K Number
K130691
Device Name
ELECTROTHERAPY DEVICE (COMBO UNIT)
Manufacturer
GUANGZHOU FINECURE MEDICAL EQUIPMENT CO.,LTD
Date Cleared
2013-12-20

(282 days)

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

TENS stands for Transcutaneous Electrical Nerve Stimulation. The device TENS system is used to provide Symptomatic relief of chronic intractable pain, Post traumatic pain and Post surgical pain.

EMS stands for Electrical Neuromuscular Stimulator. The device EMS system is indicated for:

    1. Relaxation of muscle spasm.
    1. Increase of local blood flow circulation
    1. Prevention or retardation of disuse atrophy
    1. Muscle re-education
    1. Maintaining or increasing range of motion.
  1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

IF stands for Interferential Stimulation. The device IF system is indicated for Symptomatic relief of chronic intractable pain, Post traumatic pain and Post surgical pain.

Device Description

Electrotherapy Device (Combo Unit) Model 9612

AI/ML Overview

This document is a 510(k) premarket notification decision letter for an Electrotherapy Device (Combo Unit) Model 9612. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices for the stated indications for use (TENS, EMS, and IF systems). It outlines regulatory requirements and general information for the manufacturer but does not include any performance data, clinical study details, or acceptance criteria related to a specific product performance evaluation.

§ 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).