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K Number
K964434
Device Name
SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
Manufacturer
SKYLARK DEVICE CO., LTD.
Date Cleared
1997-10-09

(338 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
    1. RELAXATION OF MUSCLE SPASM.
    1. PREVENTION OR RETARDATION OF DISUSE ATROPHY.
    1. INCREASING LOCAL BLOOD CIRCULATION.
    1. MUSCLE-RE-EDUCATION.
    1. IMMEDIATE POST SURGICAL STIMULATION OF CALF MUSCLES TO PREVENT VENOUS THROMBOSIS.
    1. MAINTAINING OR INCREASING RANGE OF MOTION.
Device Description

SD-970EMS ELECTRICAL MUSCULAR STIMULATOR

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the "SD-970EMS Electrical Muscular Stimulator," indicating that the device has been determined to be substantially equivalent to a predicate device.

The letter mentions:

  • Trade Name: SD-970EMS Electrical Muscular Stimulator
  • Regulatory Class: II
  • Product Code: IPF
  • Indications For Use: Relaxation of muscle spasm, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, and maintaining or increasing range of motion.

It does not include:

  • A table of acceptance criteria or reported device performance.
  • Details about a study (sample size, data provenance, expert numbers, adjudication methods, MRMC studies, standalone performance, ground truth types).
  • Information on training sets or how their ground truth was established.

Therefore, I cannot fulfill your request for this specific information based on 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).