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K Number
K023439
Device Name
MEDS-4 NEUROMUSCULAR STIMULATOR
Manufacturer
MEDICAL EQUIPMENT DEVICE SPECIALISTS
Date Cleared
2003-01-13

(90 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

THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS :

  • 1 . Relaxation of muscle spasms
    1. Prevention or retardation of disuse atrophy
    1. Increasing local blood circulation
  • 4 . Muscle re-education
  • Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis
  • Maintaining or increasing range of motion 6.
Device Description

MEDS-4 NEUROMUSCULAR STIMULATOR

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "MEDS-4 Neuromuscular Stimulator." It confirms that the device is substantially equivalent to legally marketed predicate devices and lists the indications for use.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information based on the input text. The 510(k) clearance letter focuses on regulatory approval based on substantial equivalence to existing devices, not on a detailed presentation of performance study results against specific acceptance criteria.

§ 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).