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K Number
K020684
Device Name
FINESUN EMS STIMULATOR
Manufacturer
FINESUN WORLDWIDE INTL. CO., LTD.
Date Cleared
2002-05-23

(80 days)

Product Code
IPF
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

For model FS-004

  • Relaxation of muscle spasms
    For models FS-008, FS-012, FS-016 and FS-020
  • Relaxation of muscle spasms
  • Prevention or retardation of disuse atrophy
  • Increasing local blood circulation
  • Muscle re-education
  • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
  • Maintaining or increasing range of motion
Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the Finesun EMS Stimulator. It does not contain information about acceptance criteria or a study proving device performance.

Therefore, I cannot answer your specific questions as the required information is not present in the provided text. This letter is focused on regulatory clearance and substantial equivalence to a predicate device, not on clinical performance studies or specific acceptance criteria for performance metrics.

§ 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).