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K Number
K984113
Device Name
MS400
Manufacturer
LSI INTL., INC.
Date Cleared
1999-01-28

(72 days)

Product Code
IPF
Regulation Number
890.5850
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Relaxation of Muscle Spasm
  • Prevention of Retardation of disuse atrophy.
  • Increasing local blood circulation
  • Muscle Re-education.
  • Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
  • Maintaining or increasing range of motion.
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter from the FDA to LSI International for their devices MS300 and MS400. This document focuses on the regulatory aspects of device approval (substantial equivalence to predicate devices) and does not contain information about specific acceptance criteria, study methodologies, or performance data of the MS300 and MS400 devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications as it is not present in the provided 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).