INTELECT

K974497 · Chattanooga Group, Inc. · GZJ · Jan 23, 1998 · Neurology

Device Facts

• Record ID: K974497
• Device Name: INTELECT
• Applicant: Chattanooga Group, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Jan 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For Russian - 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 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 Interferential and Premodulated - Symptomatic relief of chronic, intractable pain - Management of pain associated with post-traumatic or post-operative conditions Prescription Use: ☑ (Per 21 CFR 801.109)

Device Story

Intelect Legend Stim is a multi-modality electrical stimulation device used in clinical settings by healthcare professionals. It delivers Russian, Monophasic Hi-Volt, Interferential, and Premodulated currents to patients. The device transforms electrical energy into therapeutic waveforms applied via electrodes to target muscle groups or pain sites. Output parameters are controlled by the clinician to achieve muscle contraction or pain modulation. Clinical benefits include improved circulation, muscle rehabilitation, and pain management. The device serves as a therapeutic tool for physical therapy and rehabilitation workflows.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrical stimulation device providing Russian, Monophasic Hi-Volt, Interferential, and Premodulated currents. Operates via electrode-based delivery of electrical waveforms. Intended for clinical use by professionals.

Indications for Use

Indicated for patients requiring muscle spasm relaxation, prevention/retardation of disuse atrophy, increased local blood circulation, muscle re-education, maintenance/increase of range of motion, immediate postsurgical calf muscle stimulation to prevent venous thrombosis, or symptomatic relief of chronic intractable pain and 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Joe Elrod
Director of Regulatory Affairs
Chattanooga Group, Incorporated
4717 Adams Road
Hixson, Tennessee 37343

Re: K974497
Trade Name: Intelect Legend Stim
Regulatory Class: II
Product Code: GZJ, IPF and LIH
Dated: November 18, 1997
Received: November 28, 1997

Dear Mr. Elrod:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device 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.

JAN 23 1998

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Page 2 - Mr. Elrod

This letter will allow you to begin marketing your device as described in your 510(k) 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 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 device, 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,


Enclosure

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CHATTANOOGA
GROUP, INC.

# STATEMENT OF INDICATIONS FOR USE

## For Russian

- 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 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 Interferential and Premodulated

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

Prescription Use: ☑
(Per 21 CFR 801.109)


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

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