VECTRA STIM MODELS 200 AND 400

• K Number: K982321
• Device Name: VECTRA STIM MODELS 200 AND 400
• Manufacturer: CHATTANOOGA GROUP, INC.
• Date Cleared: 1999-02-01 ( 214 days)
• Product Code: GZJ , IPF , LIH
• Regulation Number: 882.5890
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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 Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Vectra 2C, 4C, 2S, 4S, Pro 2, and Pro 4). This document does not contain any information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications.

The letter primarily indicates that the devices are substantially equivalent to pre-amendment devices and can be marketed subject to general controls. It lists the indications for use of the devices but does not provide details on studies that support these indications or specific performance metrics.

Therefore, I cannot fulfill your request for the detailed information on acceptance criteria and study data based on the provided text.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. The text is in all caps and is evenly spaced around the circle.

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]

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
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.(b)
Classification. Class II (performance standards).