MUSCLE PAIN DEVICE (MPD)

• K Number: K073361
• Device Name: MUSCLE PAIN DEVICE (MPD)
• Manufacturer: STEVENS PROOF OF CONCEPT, INC.
• Date Cleared: 2008-03-18 ( 109 days)
• Product Code: IPF
• Regulation Number: 890.5850
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

• 1. Relaxation of muscle spasms.
• 2. Muscle re-education.
• 3. Maintaining or increasing range of motion.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Muscle Device (MD)." This document confirms that the device is substantially equivalent to a legally marketed predicate device.

However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any statistical details about a study to prove the device meets acceptance criteria. It primarily focuses on the regulatory clearance and compliance requirements.

Therefore, I cannot extract the requested information from this document.

Regulation Number and Section

§ 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).