VECTRA GENISYS VMS FR

K062354 · Encore Medical L.P. · IPF · Jan 26, 2007 · Physical Medicine

Device Facts

• Record ID: K062354
• Device Name: VECTRA GENISYS VMS FR
• Applicant: Encore Medical L.P.
• Product Code: IPF · Physical Medicine
• Decision Date: Jan 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For VMS-(Pulsed Mode, Burst Mode or FR Mode), 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-(Pulsed Mode, Burst Mode or FR Mode), 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 is a modular clinical electrotherapy system combining muscle stimulation, ultrasound, and sEMG biofeedback. Input modalities include surface EMG signals and user-selected therapy parameters. The device transforms these inputs via integrated clinical protocols and on-board indications to guide waveform selection, parameter settings, and electrode placement. Outputs include therapeutic electrical stimulation (various waveforms), ultrasound energy (1 or 3.3 MHz), and visual biofeedback. Used in clinical settings by healthcare providers to manage pain, muscle spasms, and facilitate rehabilitation (e.g., stroke recovery, muscle re-education). Clinicians use the 5-inch TFT LCD display to monitor patient data and adjust treatment. The system benefits patients by providing integrated, multi-modal therapy options in a single compact unit, improving clinical workflow and treatment precision.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and compliance with consensus standards (bench testing).

Technological Characteristics

Modular electrotherapy system; 5-inch TFT LCD display. Modalities: Muscle stimulation (multiple waveforms), dual-frequency ultrasound (1/3.3 MHz, 10-100% duty cycles), sEMG biofeedback. Connectivity: sEMG Data Card. Standards: UL 60601-1 (2003), IEC 60601-1-2 (2001).

Indications for Use

Indicated for patients requiring pain management, muscle spasm relaxation, muscle re-education, increased local circulation, range of motion maintenance, or prevention of disuse atrophy. Includes stroke patients for rehabilitation, patients with chronic/intractable/post-surgical/post-traumatic pain, and partially paralyzed patients requiring FES for gait improvement.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• Omnistim FX2 (K945509)
• Omnistim FX2 Pro (K945508)

Submission Summary (Full Text)

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Summary - 510(k) # K062354

Chattanooga Group, SUBMITTER: A Division of Encore Medical, L.P. 4717 Adams Road Hixson, TN 37343

JAN 2 6 2007

#### EXTABLISHMENT 1022819 REGISTRATION:

CONTACT PERSON: Michael Treas Manager of Regulatory Affairs Phone: [phone] Fax: [phone]

DATE PREPARED: October 20, 2006

#### DEVICE TRADE NAME: Vectra Genisys

CLASSIFICATION: Class II

PRODUCT CODES: IPF, IMG, GZJ, HCC, GZI, LIH

21 CFR 890.5850- Stimulator, Muscle, Powered REGULATION NUMBERS

21 CFR 890.5860- Ultrasound and muscle stimulator AND COMMON NAMES:

21 CFR 882.5890- Transcutaneous electrical nerve stimulator for pain relief

21 CFR 882.5050- Biofeedback device

21 CFR 882.5810- External functional neuromuscular stimulator

21 CFR 876.5320- Non-implantable electrical continence device

89- Physical Medicine, 84- Neurology & 78- Gastroenterology PANELS:

PREDICATE: Omnistim FX2 - K945509 Omnistim FX2 Pro - K945508

Page 1 of 3

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# Summary - 510(k) # K062354

Description: Vectra Genisys electrotherapy product lines offer clinicians a modular design of muscle stimulation, ultrasound, and biofeedback modalities in one combination device. These clinical product lines are designed to give the most treatment options in one compact and integrated package. The award winning design offers a 5 inch TFT LCD vibrant color display screen and hand held accessories.

Clinicians have a variety of choices to best suit the needs of the individual practice. Below is an overview of the system choices. The electrotherapy mode offers one of the largest selections of multiple waveforms cleared to market by the FDA. The numeric pain scales can be recorded with the patient data management system. The therapy system cart provides six concealed storage bins to conveniently house clinical essentials.

The electrotherapy module offers multiple waveforms; Interferrential, Premodulated, Asymmetrical Biphasic, Microcurrent, VMS-(Pulsed Mode, Burst Mode, and FR Mode), Russian, High Voltage Pulsed Current, Symmetrical Biphasic, Direct Current.

The dual frequency ultrasound module offers Pulsed and Continuous Duty Cycles (10%, 20%, 50%, and 100%), Low BNR (5:1), Four different size ultrasound applicators, 1cm², 2cm², and 10 cm².

The sEMG biofeedback module provides two channels of surface EMG. Feedback can be stored onto the sEMG Data Card. The sEMG features a clinician chosen trigger point that activates therapeutic stimulation. The sEMG feature is often used to treat stroke patients and for muscle re-education.

The online-guided assistance through Clinical Protocols and On-Board Indications to help guide therapy selections: electrotherapy waveform rationale, parameter selections, electrode placement images, ultrasound applicator recommendations.

The combination electrotherapy is used for the management of pain and muscle spasm. All functions of 1 or 3.3 MHz Ultrasound can be combined with Interferrential, Premodulated, Asymmetrical Biphasic, VMS-(Pulsed Mode, Burst Mode, ), and High Voltage Pulsed Current.

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# Summary - 510(k) # K062354

# Declarations of Conformity

The Vectra Genisys devices are in compliance with the following FDA recognized consensus standards:

UL 60601-1: 2003, Standards for Medical Equipment Part 1: General Requirements for Safety, l \$1 Edition

IEC 60601-1-2: 2001, Medical Electrical Equipment Part 1 - 2: General requirements for Safety - Collateral Standard, Electromagnetic Compatibility - Requirements and Tests, 2nd Edition

# Truthful and Accurate Statement

A statement attesting to the truthfulness and accuracy of the information was included in the submission.

### Further Information

In the event that additional information is required, please contact:

Michael Treas Manager of Regulatory Affairs Chattanooga Group A Division of Encore Medical, L.P. 4717 Adams Road Hixson, TN 37343-0489 U.S.A. Telephone: [phone] Fax: [phone] E-mail: Michael [e-mail]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

FEB 2 2 2007

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Encore Medical, L.P. Chattanooga Group c/o Mr. Michael Treas 4717 Adams Road Hixson, Tennessee 37343

Re: K062354

Trade Name: Vectra GENiSYS Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: II Product Code: IPF, GZJ, HCC, IMG, GZI Dated: January 26, 2007 Received: January 26, 2007

Dear Mr. Treas:

This letter corrects our substantially equivalent letter of January 26, 2007. 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.

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.

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Page 2 - Mr. Michael Treas

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/cdrb/industry/support/index.html.

Sincerely yours,

for

Mark N. Melkerson 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 | K062354 |
|---------------|----------------|
| Device Name: | Vectra Genisys |

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

# For VMS-(Pulsed Mode, Burst Mode or FR Mode), 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-(Pulsed Mode, Burst Mode or FR Mode), 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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-)
Division of General. Restorative,
and Neurological Devices

Prescription Us510(k) Number K062354
(Per 21 CFR 801.109) Over-The-Counter Use
(Optional Forma

(Optional Format 1-2-96)

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| 510(k) Number | K062354 |
|---------------|----------------|
| Device Name: | Vectra Genisys |

# 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

| 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use J (Por 21 CFR 801.109)

OR
Over-The-Counter Use
(Optional Format 1-2-96)

Mark A. Milliman

(Division Sign. 47) (Division of General. Restorative, and Neurological Devices

**510(k) Number** K 06