VECTRA COMBO

K982317 · Chattanooga Group, Inc. · IMG · Feb 1, 1999 · Physical Medicine

Device Facts

• Record ID: K982317
• Device Name: VECTRA COMBO
• Applicant: Chattanooga Group, Inc.
• Product Code: IMG · Physical Medicine
• Decision Date: Feb 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. Ultrasound can provide therapeutic deep heating between 40° and 45°C. For VMS, Russian, Monophasic Hi-Volt - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Maintaining or increasing range of motion - Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis For Microcurrent, Interferential and Premodulated - Symptomatic relief of chronic, intractable pain - Management of pain associated with post-traumatic or post-operative conditions

Device Story

Vectra series (2C, 4C, 2S, 4S, Pro 2, Pro 4) are multi-modality therapeutic devices. Inputs include electrical signals for stimulation and ultrasonic energy for thermal therapy. Device transforms electrical power into therapeutic ultrasound (deep heating 40-45°C) and various electrical stimulation waveforms (VMS, Russian, Monophasic Hi-Volt, Microcurrent, Interferential, Premodulated). Used in clinical settings by healthcare professionals. Output is applied directly to patient tissue to facilitate pain relief, muscle re-education, and circulation improvement. Clinical decision-making relies on provider selection of modality based on patient condition (e.g., post-surgical, chronic pain). Benefits include reduced muscle spasms, improved range of motion, and management of intractable pain.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multi-modality therapeutic system providing ultrasound and electrical stimulation (VMS, Russian, Monophasic Hi-Volt, Microcurrent, Interferential, Premodulated). Ultrasound provides deep heating (40-45°C). Device is a professional-use clinical unit.

Indications for Use

Indicated for patients requiring deep heat therapy for pain, muscle spasms, joint contractures, adhesive capsulitis, bursitis, myositis, and soft tissue injuries; muscle stimulation for spasm relaxation, atrophy prevention, circulation, re-education, range of motion, and venous thrombosis prevention; and pain management for chronic, intractable, post-traumatic, or post-operative conditions.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1999

Ms. Cheryl G. Dyer Regulatory Compliance Specialist Chattanooga Group, Inc. 4717 Adams Road P.O. Box 489 37343-0489 Hixson, Tennessee

K982317 Re: Trade Names: Vectra 2C and Vectra 4C Product Codes: GZJ, LIH, IPF, IMG, and IMI K982321 Trade Names: Vectra 2S and Vectra 4S GZJ, LIH, and IPF Product Codes: K982324 Vectra Pro 2 and Vectra Pro 4 Trade Names: GZJ, LIH, IPF, IMG, and IMI Product Codes: Regulatory Class: II Dated: December 10, 1999 December 11, 1999 Received:

Dear Ms. Dyer:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory

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Page 2 - Ms. Cheryl G. Dyer

In addition, FDA may publish further announcements action. concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

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

Sincerely yours,

Mark N. Wilkinson

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

Enclosures

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K982317

Image /page/2/Picture/1 description: The image shows the logo for Chattanooga Group, Inc. The logo consists of two parts: a stylized letter "C" on the left and the company name on the right. The letter "C" is formed by two curved shapes within a square. The company name is written in a bold, sans-serif font, with "Chattanooga" on the top line and "Group, Inc." on the bottom line.

## INDICATIONS

## For Ultrasound

Ultrasound for use in applying deep heat can be used for treatment of selected medical Childious such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. Ultrasound can provide therapeutic deep heating between 40° and 45°C.

For VMS, Russian, Monophasic Hi-Volt

- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation 1
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

For Microcurrent, Interferential and Premodulated

- = Symptomatic relief of chronic, intractable pain
- Management of pain associated with post-traumatic or post-operative conditions

Mark N. Milken

Prescription Use (Per 21 CFR 801.109)

4717 Adams Road P.O. Box 489 Hixson, TN 37343-0489 Phone: [phone] Fax: [phone]