VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER

K040285 · Chattanooga Group · IMG · Apr 12, 2004 · Physical Medicine

Device Facts

• Record ID: K040285
• Device Name: VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER
• Applicant: Chattanooga Group
• Product Code: IMG · Physical Medicine
• Decision Date: Apr 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES), Interferential and Premodulated (IFS) 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 Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS, VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS) Symptomatic relief or management of chronic, intractable pain Post-traumatic acute pain Post-surgical acute pain For FES Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait For DC Continuous Mode Relaxation of muscle spasm For Ultrasound Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: 1. Relief of pain, muscle spasms and joint contractures 2. Relief of pain, muscle spasms and joint contractures that may be associated with: a) Adhesive capsulitis b) Bursitis with slight calcification c) Myositis d) Soft tissue injuries e) Shortened tendons due to past injuries and scar tissues 3. Relief of sub-chronic and chronic pain and joint contractures resulting from: a) Capsular tightness b) Capsular scarring

Device Story

Vectra GENiSYS is a multi-modality therapeutic device combining ultrasound and electrical stimulation. It delivers therapeutic deep heat via ultrasound for musculoskeletal conditions and various electrical stimulation waveforms (VMS, Russian, Hi-Volt, Interferential, Premodulated, TENS, Microcurrent, FES, DC) for pain management, muscle re-education, and spasm reduction. Used in clinical settings by healthcare professionals. The device transforms electrical energy into therapeutic ultrasound or electrical pulses applied to the patient via applicators/electrodes. Clinicians select parameters based on patient condition to manage pain or improve physical function. Benefits include non-invasive pain relief, improved circulation, and functional gait improvement for partially paralyzed patients.

Clinical Evidence

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

Technological Characteristics

Multi-modality system providing ultrasound and electrical stimulation. Waveforms include VMS, VMS Burst, Russian, Monophasic Hi-Volt, Interferential, Premodulated, Microcurrent, Asymmetrical/Symmetrical Biphasic (TENS), FES, and DC. Operates as a therapeutic stimulator and ultrasound generator. Connectivity and specific material standards are not detailed in the provided documentation.

Indications for Use

Indicated for patients requiring muscle spasm relaxation, disuse atrophy prevention, local blood circulation increase, muscle re-education, range of motion maintenance, or venous thrombosis prevention via postsurgical calf stimulation. Also indicated for symptomatic relief of chronic, intractable, post-traumatic, or post-surgical pain. FES indicated for partially paralyzed patients to improve gait via leg/ankle muscle stimulation. Ultrasound indicated for sub-chronic/chronic pain, muscle spasms, and joint contractures associated with conditions like adhesive capsulitis, bursitis, myositis, soft tissue injuries, and scar tissue.

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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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2004

Mr. Mick Davis Regulatory Analyst Chattanooga Group A Division of Encore Medical 4717 Adams Road P.O. Box 489 Hixson, Tennessee 37343-0489

Re: K040285

Trade Name: Vectra GENiSYS Regulation Numbers: 21 CFR 890.5860, 882.5890, 890.5850, 882.5810 Regulation Names: Ultrasound and muscle stimulator, Transcutaneous electrical nerve stimulator for pain relief, Powered muscle stimulator, External functional neuromuscular stimulator Regulatory Class: II

Product Codes: IMG, GZJ, IPF, GZJ

Trade Name: Vectra GENiSYS Regulation Number: Unclassified Regulation Name: Interferential current therapy stimulator Regulatory Class: II Product Code: LIH

Dated: February 5, 2004 Received: February 17, 2004

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devicc Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Mr. Mick Davis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A. Millican

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

Enclosure

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510(k) Number (if known): Vectra (Intelect) Transportable Combo & Stim Device Name:

Indications for Use:

## For VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES), Interferential and Premodulated (IFS)

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

Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS, VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS)

Symptomatic relief or management of chronic, intractable pain

Post-traumatic acute pain

Post-surgical acute pain

#### For FES

Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait

#### For DC Continuous Mode

Relaxation of muscle spasm

#### For Ultrasound

Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

1. Relief of pain, muscle spasms and joint contractures

2. Relief of pain, muscle spasms and joint contractures that may be associated with:

a) Adhesive capsulitis

b) Bursitis with slight calcification

c) Myositis

d) Soft tissue injuries

e) Shortened tendons due to past injuries and scar tissues

3. Relief of sub-chronic and chronic pain and joint contractures resulting from:

a) Capsular tightness

b) Capsular scarring

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============================================================================================================================================================================== Concurrence of CDRH, Office of Device Evaluation

# Division of General. Restorative. and Neurological Devices

Prescription Use
(Per 21 CFR 801.109)

**10(k) Number** K040285

(Optional Format 1-2-96)