VECTORSURGE 5 MODEL 470

• K Number: K030648
• Device Name: VECTORSURGE 5 MODEL 470
• Manufacturer: METRON MEDICAL AUSTRALIA PTY LTD
• Date Cleared: 2003-03-28 ( 28 days)
• Product Code: IPF , GZJ , LIH
• Regulation Number: 890.5850
• Type: Special
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

The indications for use are:

1. Relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (TNS Mode);
2. Relaxation of muscle spasm (Interferential Mode);
3. Prevention or retardation of disuse atrophy (Interferential Mode);
4. Increasing local blood flow (Interferential Mode);
5. Muscle re-education (Interferential Mode);
6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (Interferential Mode); and
7. Maintaining or increasing range of motion (Interferential Mode).

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the text provided, I cannot answer your question. The document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Vectorsurge 5 Model VS 470." It discusses regulatory classifications, general controls, and indications for use, but it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details about a multi-reader multi-case comparative effectiveness study or standalone algorithm performance.

The document primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing the device.

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).