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K Number
K132137
Device Name
MULTISTIM
Manufacturer
METRON MEDICAL AUSTRALIA PTY LTD
Date Cleared
2013-09-12

(63 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
  • I. Relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential, TNS and Microcurrent waveforms);
    1. Relaxation of muscle spasm (all waveforms except Microcurrent);
    1. Prevention or retardation of disuse atrophy (all waveforms except Microcurrent);
    1. Increasing local blood flow (all waveforms except Microcurrent);
    1. Muscle re-education (all waveforms except Microcurrent);
    1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (all waveforms except Microcurrent); and
    1. Maintaining or increasing range of motion (all waveforms except Microcurrent).
Device Description

Not Found

AI/ML Overview

This FDA 510(k) clearance letter for the Metron Multi-Stim Model MS-100A does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The document is a clearance letter, which means the FDA has determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on a comparison to existing devices, and typically involves demonstrating similar technological characteristics and performance specifications. However, the letter itself does not provide the details of those performance specifications or the studies conducted to demonstrate them.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them because that information is not present in the provided text.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates a comparison to predicate devices, but the specifics of how that substantial equivalence was demonstrated (i.e., performance criteria and study results) are not elaborated upon in this letter.

§ 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).