VECTORSONIC, MODEL VU-200

• K Number: K020119
• Device Name: VECTORSONIC, MODEL VU-200
• Manufacturer: METRON MEDICAL AUSTRALIA PTY LTD
• Date Cleared: 2002-07-22 ( 189 days)
• Product Code: IMG
• Regulation Number: 890.5860
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

The indications for use for the interferential therapy are:

1. Relaxation of muscle spasm;
2. Prevention or retardation of disuse atrophy;
3. Increasing local blood flow;
4. Muscle re-education;
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
6. Maintaining or increasing range of motion.

The indications for use for the ultrasound therapy are:

1. Relief or reduction of pain;
2. Reduction of muscle spasm;
3. Joint contracture; and
4. Local increase in circulation.

The indication for use for the combined therapy is:

1. Reduction of muscle spasm.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, any specific study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. The document is an FDA 510(k) clearance letter for the Vectorsonic Model VU-200, which outlines its indications for use and regulatory classification, but does not contain the detailed study information you've requested.

Regulation Number and Section

§ 890.5860 Ultrasound and muscle stimulator.

(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.