MEDS-3 NEUROMUSCULAR STIMULATOR

• K Number: K023443
• Device Name: MEDS-3 NEUROMUSCULAR STIMULATOR
• Manufacturer: MEDICAL EQUIPMENT DEVICE SPECIALISTS
• Date Cleared: 2003-01-13 ( 90 days)
• Product Code: GZJ
• Regulation Number: 882.5890
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria for a device, a study that proves the device meets those criteria, or any of the detailed aspects like sample sizes, expert qualifications, adjudication methods, or specific study types.

The document is a clearance letter from the FDA regarding a 510(k) premarket notification for the "MEDS-3 Neuromuscular Stimulator." It primarily states that the device has been determined to be substantially equivalent to a legally marketed predicate device for the symptomatic relief of chronic intractable pain. It outlines the regulatory classification and general controls applicable to the device but does not include performance data, study designs, or acceptance criteria.

Regulation Number and Section

§ 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).