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K Number
K032941
Device Name
AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
Manufacturer
RICH-MAR CORP.
Date Cleared
2003-10-22

(30 days)

Product Code
IPF,GZJ,IMG,IMI,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.
  • Prevention or retardation of disuse atrophy. 2.
    1. Increasing local blood circulation.
    1. Muscle re-education.
    1. Maintaining or increasing range of motion.
  • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. 6.

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.

Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:

    1. Relief of pain
    1. Muscle spasms
    1. Joint contractures

But NOT for the treatment of malignancies

Device Description

Not Found

AI/ML Overview

The provided text is a Letter of Substantial Equivalence from the FDA for a device called "Rich-Mar AutoSound 7.6". This document does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The letter essentially states that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed. It lists the indications for use of the device but offers no performance metrics, study designs, or data to support any acceptance criteria.

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

§ 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).