VECTRA PRO MODELS 2 AND 4

K982324 · Chattanooga Group, Inc. · GZJ · Feb 1, 1999 · Neurology

Device Facts

• Record ID: K982324
• Device Name: VECTRA PRO MODELS 2 AND 4
• Applicant: Chattanooga Group, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Feb 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• 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 electrotherapy and ultrasound systems. Devices deliver therapeutic ultrasound for deep tissue heating (40-45°C) and various electrical stimulation waveforms (VMS, Russian, Monophasic Hi-Volt, Microcurrent, Interferential, Premodulated). Operated by clinicians in clinical settings; devices provide physical therapy interventions. Ultrasound modality targets soft tissue injuries and joint conditions; electrical stimulation modalities target muscle function and pain management. Output affects clinical decision-making by providing non-invasive physical therapy modalities to improve patient mobility, reduce pain, and prevent atrophy/thrombosis.

Clinical Evidence

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

Technological Characteristics

Multi-modality system combining ultrasound and electrical stimulation (VMS, Russian, Hi-Volt, Microcurrent, Interferential, Premodulated). Ultrasound provides deep heating (40-45°C). Electrical stimulation provides muscle re-education and pain management. Devices are intended for professional clinical use.

Indications for Use

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

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

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 Requlatory Compliance Specialist Chattanooga Group, Inc. 4717 Adams Road P.O. Box 489 37343-0489 Hixson, Tennessee

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

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, Drug, 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, good 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 Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory

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Page 2 - Ms. Cheryl G. Dyer

action. In addition, FDA may publish further announcements 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 requlations.

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 in 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 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,

ho. Marle N. Milkeran

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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K982324

Image /page/2/Picture/1 description: The image shows the logo for Chattanooga Group, Inc. The logo consists of a stylized letter "C" on the left, with the words "Chattanooga" above the words "Group, Inc." on the right. The letter "C" is made up of black and white shapes, and the words are in a simple, sans-serif font.

## INDICATIONS

## For Ultrasound

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 I
- Muscle re-education
- 피 Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis L

For Microcurrent, Interferential and Premodulated

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

Mark M Milluson

fo

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K98 2324

Prescription Use
(Per 21 CFR 801.109)

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