VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM

K031077 · Chattanooga Group · IMG · Dec 11, 2003 · Physical Medicine

Device Facts

• Record ID: K031077
• Device Name: VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM
• Applicant: Chattanooga Group
• Product Code: IMG · Physical Medicine
• Decision Date: Dec 11, 2003
• 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 EMG To determination the activation timing of muscles for: a) retraining of muscle activation b) coordination of muscle activation An indication of the force produced by muscle for control and maintenance of muscle contractions Relaxation muscle training Muscle re-education For EMG triggered Stim Stroke rehab by muscle re-education Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increase local blood circulation Muscle re-education Maintaining or increasing range of motion 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 (also known as Intelect Legend XT) is a multi-modality therapeutic device for clinical use by healthcare professionals. It integrates ultrasound, electrical muscle stimulation (NMES, FES, Russian, Hi-Volt, Interferential, TENS, Microcurrent), and EMG biofeedback. Device inputs include electrical signals from patient muscles (EMG) and user-selected therapeutic parameters. The device processes these inputs to deliver targeted electrical stimulation or ultrasound energy to patient tissues. Outputs include therapeutic deep heat, muscle stimulation for rehabilitation/gait, and visual/auditory EMG feedback for muscle retraining. Clinicians use the device to manage pain, improve range of motion, and facilitate neuromuscular rehabilitation. The system aids clinical decision-making by providing objective data on muscle activation timing and force, allowing for tailored rehabilitation protocols. Benefits include reduced muscle spasms, improved functional mobility, and effective pain management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multi-modality system combining ultrasound and electrical stimulation. Modalities include NMES, FES, TENS, Interferential, Russian, Hi-Volt, Microcurrent, and EMG biofeedback. Operates as a standalone clinical unit. Software-controlled parameters for energy delivery. No specific materials or ASTM standards cited.

Indications for Use

Indicated for patients requiring muscle spasm relaxation, disuse atrophy prevention, blood circulation improvement, muscle re-education, range of motion maintenance, venous thrombosis prevention, pain management (chronic, intractable, post-traumatic, post-surgical), gait improvement via FES in partially paralyzed patients, and therapeutic deep heat for sub-chronic/chronic conditions (e.g., bursitis, myositis, soft tissue injuries, joint contractures).

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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 - 2004

Ms. Cheryl Bagwell Director of Regulatory Affairs Chattanooga Group A Division of Encore Medical 4717 Adams Road P.O. Box 489 Hixson, Tennessee 37343-0489

Re: K031077

Trade Name: Vectra GENiSYS Regulation Numbers: 21 CFR 890.5860, 882.5890, 890.5850, 882.5050, 882.5810 Regulation Names: Ultrasound and muscle stimulator, Transcutaneous electrical nerve stimulator for pain relief, Powered muscle stimulator, Biofeedback device, External functional neuromuscular stimulator Regulatory Class: II Product Codes: IMG, GZJ, IPF, HCC, GZI

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

Dear Ms. Bagwell:

:

This letter corrects our substantially equivalent letter of December 11, 2003 regarding the Vectra GENiSYS Indications for use enclosure.

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 Device 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.

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Page 2 - Ms. Cheryl Bagwell

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.

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 vo

Mark A Milliken

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): K031077 Vectra GENiSYS (Intelect Legend XT) Device Name:

### Indications for Use: (Page 1 of 2)

## 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 EMG

To determination the activation timing of muscles for:

- a) retraining of muscle activation
- b) coordination of muscle activation

An indication of the force produced by muscle for control and maintenance of muscle contractions

Relaxation muscle training

Muscle re-education

노르트워크로드오 노르드루비스

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

Prescription Use (Per 21 CFR 801.109)

OR

KO31077 510 Ry Ninnberter Use

(Optional Format 1-2-96)

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#### 510(k) Number (if known): K031077 Vectra GENiSYS (Intelect Legend XT) Device Name:

# Indications for Use: (Page 2 of 2)

| For EMG triggered Stim |
|---------------------------------------------|
| Stroke rehab by muscle re-education |
| Relaxation of muscle spasms |
| Prevention or retardation of disuse atrophy |
| Increase local blood circulation |
| Muscle re-education |
| Maintaining or increasing range of motion |

### For Ultrasound

(Per 21 CFR 801.109)

| 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<br>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 | |

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE JE EDED) Concurrence of CDRH, Office of Device aluatio (Di ision Sign-Off) Division of General, Restorative, and Neurological Devices K031077 Prescription Use Over 1948 Status Post OR

(Optional Format 1-2-96)