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K Number
K032055
Device Name
MEDS-4-INF+
Manufacturer
MEDICAL EQUIPMENT DEVICE SPECIALISTS
Date Cleared
2003-10-03

(93 days)

Product Code
GZJ,IPF,LIH
Regulation Number
882.5890
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

AS A POWERED MUSCLE STIMULATOR

  • 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

AS A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR

  • SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN

AS AN INTERFERENTIAL CURRENT STIMULATOR

  • SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN
  • SYMPTOMATIC RELIEF OF ACUTE PAIN
Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the MEDS-4-INF+ Stimulator, determining its substantial equivalence to legally marketed predicate devices. It lists the approved indications for use as a Powered Muscle Stimulator, a Transcutaneous Electrical Nerve Stimulator, and an Interferential Current Stimulator.

However, this document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, nor any of the other specific details requested in the prompt (sample sizes, ground truth, expert qualifications, etc.).

Therefore, I cannot provide the requested information based on the input document.

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).