MEDS-4 NEUROMUSCULAR STIMULATOR

• K Number: K023435
• Device Name: MEDS-4 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 based on the provided text, I cannot provide details on the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a Neuromuscular Stimulator. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information. However, it does not contain any information about specific acceptance criteria, study methodologies, sample sizes, expert qualifications, ground truth establishment, or performance metrics for the MEDS-4 Neuromuscular Stimulator itself. The document is primarily an administrative approval notice, not a detailed technical report of a clinical study.

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).