VECTRA STIM MODELS 200 AND 400

K982321 · Chattanooga Group, Inc. · GZJ · Feb 1, 1999 · Neurology

Device Facts

• Record ID: K982321
• Device Name: VECTRA STIM MODELS 200 AND 400
• 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

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 electrical stimulation devices used in clinical settings by healthcare professionals. Devices deliver various waveforms including VMS, Russian, Monophasic Hi-Volt, Microcurrent, Interferential, and Premodulated currents. Inputs are user-selected parameters; device transforms these into therapeutic electrical outputs applied via electrodes to patient tissue. Output affects muscle physiology (spasm reduction, atrophy prevention, circulation, re-education, ROM) or modulates pain signaling. Clinicians use device to manage post-surgical, post-traumatic, or chronic pain conditions and facilitate physical rehabilitation. Benefits include improved muscle function and pain management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Electrical stimulation device providing multiple waveforms: VMS, Russian, Monophasic Hi-Volt, Microcurrent, Interferential, and Premodulated. Form factor is a clinical console unit. Operates via electrical current delivery to patient tissue. No specific materials, software architecture, or connectivity details provided.

Indications for Use

Indicated for patients requiring muscle spasm relaxation, prevention of disuse atrophy, increased local blood circulation, muscle re-education, range of motion maintenance, or postsurgical calf muscle stimulation to prevent venous thrombosis. Also indicated for patients requiring symptomatic relief of chronic, intractable pain or management of post-traumatic/post-operative pain.

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

K982317 Re: Vectra 2C and Vectra 4C Trade Names: GZJ, LIH, IPF, IMG, and IMI Product Codes: K982321 Vectra 2S and Vectra 4S Trade Names: Product Codes: GZJ, LIH, and IPF K982324 Vectra Pro 2 and Vectra Pro 4 Trade Names: GZJ, LIH, IPF, IMG, and IMI Product Codes: Regulatory Class: II December 10, 1999 Dated: 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, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class (Special Controls) or class III (Premarket Approval), they II 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 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,

le Mark n mllkerson

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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K982321

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, followed by the words "CHATTANOOGA" on the top line and "GROUP, INC." on the bottom line. A horizontal line separates the two lines of text. The logo is black and white.

## INDICATIONS

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 를

For Microcurrent, Interferential and Premodulated

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

Mark M. Milkerson

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982321

**Prescription Use**
(Per 21 CFR 801.109)

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