AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION

• K Number: K972997
• Device Name: AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION
• Manufacturer: DAN MED, INC.
• Date Cleared: 1997-11-10 ( 90 days)
• Product Code: IPF , IPE
• Regulation Number: 890.5850
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

Stroke Rehab by Muscle Reeducation Relaxation of muscle spasms. Prevention of retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Maintaining or increasing range of motion.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the "AM800 AutoMove EMG Triggered Electrical Muscle Stimulation" device.

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

The letter is a notification of substantial equivalence to a legally marketed predicate device, allowing the device to be marketed. It does not include the technical details or study reports that would contain the requested information about device performance and validation.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

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).