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K Number
K013770
Device Name
MODIFICATION TO: WINNER ST-2 STIMULATOR
Manufacturer
RICH-MAR CORP.
Date Cleared
2002-01-18

(66 days)

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

Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms:

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

Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms:

    1. Symptomatic relief of chronic intractable pain.
    1. Management of pain associated with post-traumatic or post operative conditions.
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Rich-Mar Winner ST-2, a muscle stimulator and TENS unit). It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details you requested regarding a medical device study.

Therefore, I cannot extract the requested information from the given text. This document serves as regulatory clearance based on substantial equivalence to predicate devices, not a detailed report of a performance study.

§ 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).