VECTORSONIC, MODEL VU-200

K020119 · Metron Medical Australia, Pty, Ltd. · IMG · Jul 22, 2002 · Physical Medicine

Device Facts

• Record ID: K020119
• Device Name: VECTORSONIC, MODEL VU-200
• Applicant: Metron Medical Australia, Pty, Ltd.
• Product Code: IMG · Physical Medicine
• Decision Date: Jul 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The indications for use for the interferential therapy are: - Relaxation of muscle spasm; 1. - Prevention or retardation of disuse atrophy; 2. - Increasing local blood flow; 3. - Muscle re-education; 4. - Immediate post-surgical stimulation of calf muscles to prevent 5. venous thrombosis; and - Maintaining or increasing range of motion. 6. The indications for use for the ultrasound therapy are: - Relief or reduction of pain; 1. - 2. Reduction of muscle spasm; - Joint contracture; and 3. - Local increase in circulation. 4. The indication for use for the combined therapy is: - Reduction of muscle spasm. 1.

Device Story

Vectorsonic Model VU-200 provides interferential therapy, ultrasound therapy, or combined therapy. Device delivers electrical stimulation for muscle-related indications and ultrasonic energy for pain and circulation. Used in clinical settings by healthcare professionals. Output affects clinical decision-making by facilitating physical therapy protocols for muscle and joint rehabilitation. Benefits include reduced muscle spasms, improved circulation, and prevention of post-surgical complications.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Class II device (21 CFR 890.5860). Combines ultrasound and electrical muscle stimulation. Operates as a therapeutic modality for physical medicine.

Indications for Use

Indicated for patients requiring physical therapy for muscle spasm relaxation, prevention of disuse atrophy, increased local blood flow, muscle re-education, post-surgical calf stimulation to prevent venous thrombosis, range of motion maintenance, pain relief, and joint contracture reduction.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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## JUL 2 2 2002

## Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dave Toman Metron Medical Australia Pty. Ltd. · 57 Aster Avenue (P.O. Box 2164) Carrum Downs Victoria. Australia 3201

Re: K020119

Trade/Device Name: Vectorsonic Model VU-200 Regulation Number: 21 CFR 890.5860 Regulation Name: Ultrasound and muscle simulator Regulatory Class: Class II Product Code: IMG Dated: April 17, 2002 Received: April 23, 2002

Dear Mr. Toman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k)

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Page 2 - Mr. Toman

premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device ~ to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510 (k) NUMBER (IF KNOWN): | K020119 |
|----------------------------|-----------------------------|
| DEVICE NAME: | Vectorsonic<br>Model VU 200 |

## INDICATIONS FOR USE:

The indications for use for the interferential therapy are:

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

The indications for use for the ultrasound therapy are:

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

The indication for use for the combined therapy is:

- Reduction of muscle spasm. 1.
Mark N Millerson
Division Sign Off

eral, Restorative and Neuro incri

Concurrence of CDRH, Office of Device Evaluationgry(仅只是;

Prescription Use (Per 21 CFR 801.109) OR

:Over-The-Counter-Use (Optional Format 1-2-96)