BTL-4000

K150353 · BTL Industries, Inc. · IMG · Nov 13, 2015 · Physical Medicine

Device Facts

• Record ID: K150353
• Device Name: BTL-4000
• Applicant: BTL Industries, Inc.
• Product Code: IMG · Physical Medicine
• Decision Date: Nov 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

ELECTROTHERAPY VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES). Interferential and Premodulated (IFS) are indicated for relaxation of muscle spasms; prevention of disuse atrophy; increase of local blood circulation; muscle reeducation; maintaining or increasing range of motion and immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. Microcurrent, Interferential, Premodulated (IFS), VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS) are indicated for symptomatic relief and management of chronic, intractable pain; post-traumatic acute pain and post-surgical acute pain. FES is indicated for 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. DC Continuous Mode is indicated for relaxation of muscle spasm. ULTRASOUND THERAPY Ultrasound module is indicated for an application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: relief of pain, muscle spasms and joint contractures; relief of pain, muscle spasms and joint contractures that may be associated with: adhesive capsultis, with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues; relief of sub-chronic pain and joint contractures resulting from: capsular tightness, capsular scaring. LASER THERAPY Laser module is indicated for topical heating for: temporary increase of local blood circulation; temporary relief of minor muscle and joint aches, pains, and stiffness; relaxation of muscles; temporary relief of muscle spasms and temporary relief of minor pain and stiffness associated with arthritis.

Device Story

BTL-4000 is a professional physiotherapy system comprising electrotherapy, ultrasound, and laser therapy modules; operated by clinicians in clinical settings. Electrotherapy delivers electrical currents via skin electrodes to stimulate nerves/muscles. Ultrasound uses piezoceramic transducers (Pz26, NCE41) to convert mechanical energy into deep tissue heat. Laser therapy applies coherent, polarized, monochromatic light via probes or clusters for topical heating. Device features a 7-inch color touchscreen for protocol selection; allows configuration of therapy parameters. Output affects clinical decision-making by providing non-invasive options for pain relief, muscle rehabilitation, and tissue healing. Benefits include improved patient mobility, pain management, and recovery from musculoskeletal injuries.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of technical characteristics to predicate devices.

Technological Characteristics

System includes electrotherapy, ultrasound, and laser modules. Ultrasound uses piezoceramic crystals (Pz26, NCE41). Laser uses diodes (685-830 nm). Electrical safety: Class II, BF. Connectivity: Standalone with 7-inch color touchscreen. Standards: IEC 60601-1, 60601-1-2, 60601-2-5, 60601-2-10, 60601-2-22, 60825-1, ISO 10993-1/5/10, IEC 62304.

Indications for Use

Indicated for patients requiring muscle stimulation (spasms, atrophy, reeducation, circulation, ROM, post-surgical calf stimulation, gait improvement in partially paralyzed patients), pain management (chronic, intractable, post-traumatic, post-surgical), and therapeutic deep heat or topical heating for musculoskeletal conditions (pain, spasms, contractures, arthritis, soft tissue injuries).

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.

Predicate Devices

• Vectra Genisys (K031077)
• Vectra Genisys Laser Module (K040662)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 13, 2015

BTL Industries, Inc. Attn: Mr. Jan Zarsky Executive Vice President 47 Loring Drive Framingham, MA 01702

> Re: K150353 Trade Name: BTL-4000 Regulation Number: 21 CFR 890.5860 Regulation Name: Ultrasound and muscle stimulator Regulatory Class: Class II Product Code: IMG, IPF, GZJ, GZI, LIH, ILY Dated: October 12, 2015 Received: October 14, 2015

Dear Mr. Zarsky:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code 27f 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Carlos L. Pena-S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K150353

Device Name BTL-4000

Indications for Use (Describe) ELECTROTHERAPY

VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES). Interferential and Premodulated (IFS) are indicated for relaxation of muscle spasms; prevention of disuse atrophy; increase of local blood circulation; muscle reeducation; maintaining or increasing range of motion and immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

Microcurrent, Interferential, Premodulated (IFS), VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS) are indicated for symptomatic relief and management of chronic, intractable pain; post-traumatic acute pain and post-surgical acute pain.

FES is indicated for 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.

DC Continuous Mode is indicated for relaxation of muscle spasm.

#### ULTRASOUND THERAPY

Ultrasound module is indicated for an application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: relief of pain, muscle spasms and joint contractures; relief of pain, muscle spasms and joint contractures that may be associated with: adhesive capsultis, with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues; relief of sub-chronic pain and joint contractures resulting from: capsular tightness, capsular scaring.

### LASER THERAPY

Laser module is indicated for topical heating for: temporary increase of local blood circulation; temporary relief of minor muscle and joint aches, pains, and stiffness; relaxation of muscles; temporary relief of muscle spasms and temporary relief of minor pain and stiffness associated with arthritis.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image shows a logo for BTL, which is a telecommunications company in Belize. The logo consists of three blue diamonds that are interlocked. The letters "BTL" are written in white inside the diamonds. The logo is simple and modern, and it is easily recognizable.

# Section 5 - 510(k) Summary

## General Information

| Sponsor: | BTL Industries, Inc.<br>47 Loring Drive<br>Framingham, MA 01702<br>Tel: [phone]<br>Fax: [phone] |
|------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.<br>47 Loring Drive<br>Framingham, MA 01702<br>Tel: [phone]<br>Fax: [phone] |

- Contact Person: Jan Zarsky BTL Industries, Inc. Executive VP [e-mail]
Summary Preparation 5 February, 2015 Date:

### Device Names

Trade/Proprietary Name: BTL-4000

Classification Name:

21 CFR 890.5300 Ultrasonic diathermy 21 CFR 890.5500 Infrared lamp 21 CFR 890.5850 Powered muscle stimulator 21 CFR 890.5860 Ultrasound and Muscle stimulator 21 CFR 882.5890 TENS for pain relief 21 CFR 882.5810 External functional neuromuscular stimulator

Product Code:

GZI - Stimulator, Neuromuscular, External Functional GZJ - Stimulator, Nerve, Transcutaneous, for Pain Relief ILY - Lamp, Infrared, Therapeutic Heating IMG - Stimulator, Ultrasound and Muscle, for Use in Applying Therapeutic Deep Heat IPF - Stimulator, Muscle, Powered LIH - Interferential Current Therapy

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Image /page/5/Picture/0 description: The image shows a logo with three interconnected blue squares. Each square has a letter inside: 'B', 'T', and 'L' respectively. The squares are arranged horizontally and slightly overlap, creating a linked chain effect. The logo appears to be for an organization or company with the initials BTL.

## Legally Marketed Predicate Devices

BTL-4000 is substantially equivalent to the current products that are already cleared for USA distribution under the following 510(k) Premarket Notification numbers:

- Vectra Genisys Chattanooga Medical Supply, Inc. (K031077) .
- . Vectra Genisys Laser Module - Chattanooga Medical Supply, Inc. (K040662)

## Product Description

BTL-4000 is a professional physiotherapy device. Depending on the required configuration, the device can consist of up to three generators - electrotherapy, ultrasound therapy and laser therapy.

Electrotherapy is a non-invasive therapeutic method based on electrical current flow through the human tissues. The electric current is applied with the use of electrodes directly through the patient's skin. The use of electrotherapy is accepted in the field of rehabilitation. Ultrasound therapy is a non-invasive therapeutic method, which uses mechanical energy of the longitudinal waves penetrating deep through human soft-tissues. Mechanical waves are absorbed in the tissues and transformed into heat energy.Low-level laser therapy is a noninvasive therapeutic method based on the application of coherent, polarized, monochromatic light in the form of a laser beam. The laser beam is absorbed in the tissues.

BTL-4000 is equipped with a colour touch screen, which considerably simplifies its operation. Therapy is simply started by a quick selection from the list of the most frequently used therapeutic protocols or by selecting from the list of all therapeutic protocols. A sophisticated function of the device is the possibility to select the optimum therapy according to the required therapeutic effect or according to the place of application.

The BTL-4000 consists of the following main components:

- . control unit
- user interface with 7" LCD color touch screen ●
- therapy modules electrotherapy, ultrasound and laser .
- accessories depends on the combination - electrotherapy electrodes
- laser probe/cluster
- । ultrasound head/HandsFree sono handpiece

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Image /page/6/Picture/0 description: The image shows a logo with three blue diamond shapes connected together. Inside the diamonds are the letters "BTL". Below the logo is the text "Indications for Use" in a bold, sans-serif font. The text is black and centered below the logo.

### For Electrotherapy

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

- relaxation of muscle spasms -
- prevention or retardation of disuse atrophy -
- increase of 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 and 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 Continunous 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:

- relief of pain, muscle spasms and joint contractures ।
- relief of pain, muscle spasms and joint contractures that may be associated with:
- adhesive capsulitis
- bursitis with slight calcification
- I myositis
- soft tissue injuries
- shortened tendons due to past injuries and scar tissues

relief of sub-chronic, chronic pain and joint contractures resulting from:

- capsular tightness .
- capsular scarring .

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Image /page/7/Picture/0 description: The image shows a logo with the letters BTL inside of three squares. Below the logo is the text "For Laser:", followed by the text "Is indicated for topical heating for:". The text is in black font and is left-aligned.

- temporary increase of local blood circulation
- temporary relief of minor muscle and joint aches, pains, and stiffness -
- relaxation of muscles
- temporary relief of muscle spasms -
- temporary relief of minor pain and stiffness associated with arthritis -

## Non-clinical Testing

The BTL-4000 device has been thoroughly evaluated for electrical safety. The BTL-4000 has been found to conform with applicable medical device safety standards. The system complies with the following standards:

ISO 14971 - Medical devices - Application of risk management to medical devices IEC 62304 - Medical Device Software - Software Life Cycle Processes

### Medical Electrical Equipment

- General requirements for safety IEC 60601-1
- IEC 60601-1-2 Electromagnetic compatibility-Requirements and Tests
- IEC 60601-2-5 Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
- IEC 60601-2-10 Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- IEC 60601-2-22 Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1 Safety of laser products - Part 1: Equipment classification and requirements
- IEC 60601-1-6 General requirements for basic safety and essential performance -Collateral standard: Usability
- Evaluation and testing within a risk management process ISO 10993-1
- ISO 10993-5 Biological Evaluation of Medical Devices-Tests for In Vitro toxicity
- ISO 10993-10 Biological Evaluation of Medical Devices-Test for Irritation and Skin Sensitization
- ISO 14971 Medical devices Application of risk management to medical devices IEC 62304 - Medical Device Software - Software Life Cycle Processes

## Clinical testing

The substantial equivalence determination for the BTL-4000 is not based upon clinical performance testing. The device safety and efficacy was demonstrated by comparison of technical characteristics between the BTL-4000 and compared to the predicate device.

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Image /page/8/Picture/0 description: The image shows a logo with three interconnected blue diamonds. Inside each diamond is a letter, spelling out "BTL". The letters are also in blue, matching the color of the diamonds. The logo has a clean and modern design.

## Comparison with the Predicate Device

| Device Name | BTL-4000 | Vectra Genisys | Vectra Genisys Laser<br>System |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | BTL Industries, Inc. | Chattanooga Medical Supply, Inc. | Chattanooga Medical<br>Supply, Inc. |
| 510(k) Number | Current submission | K031077 | K040662 |
| Intended Use | For VMS, VMS Burst, Russian,<br>Monophasic Hi-Volt (NMES), Interferential<br>and Premodulated (IFS):<br>- relaxation of muscle spasms<br>- prevention or retardation of disuse<br>atrophy<br>- increase of local blood circulation<br>- muscle re-education<br>- maintaining or increasing range of<br>motion<br>- immediate postsurgical stimulation of<br>calf muscles to prevent venous<br>thrombosis<br>Additionally for Microcurrent,<br>Interferential, Premodulated (IFS), VMS,<br>VMS Burst, Asymmetrical Biphasic<br>(TENS) and Symmetrical Biphasic<br>(TENS):<br>- symptomatic relief and management of<br>chronic, intractable pain<br>- post-traumatic acute pain<br>- post-surgical acute pain<br>For FES:<br>Stimulation of the muscles in the leg and<br>ankle of partially paralyzed patients to<br>provide flexion of the foot and thus<br>improve the patient's gait.<br>For DC Continuous Mode:<br>- Relaxation of muscle spasm<br>For Laser:<br>the laser module is indicated for topical<br>heating for:<br>-temporary increase in local blood<br>circulation<br>-temporary relief of minor muscle and<br>joint aches, pains, and stiffness<br>-relaxation of muscles<br>-temporary relief of muscle spasms<br>-temporary relief of minor pain and<br>stiffness associated with arthritis<br>For Ultrasound<br>Application of therapeutic deep heat for<br>the treatment of selected sub-chronic and<br>chronic medical conditions such as:<br>- relief of pain, muscle spasms and joint<br>contractures<br>- relief of pain, muscle spasms and joint<br>contractures that may be associated with:<br>-adhesive capsulitis<br>-bursitis with slight calcification<br>-myositis<br>-soft tissue injuries<br>-shortened tendons due to past injuries<br>and scar tissues<br>-relief of sub-chronic, chronic pain and<br>joint contractures resulting from:<br>-capsular tightness<br>-capsular scarring | For VMS, VMS Burst, Russian,<br>Monophasic Hi-Volt (NMES), Interferential<br>and Premodulated (IFS):<br>- relaxation of muscle spasms<br>- prevention or retardation of disuse atrophy<br>- increase of local blood circulation<br>- muscle re-education<br>-maintaining or increasing range of motion<br>- immediate postsurgical stimulation of calf<br>muscles to prevent venous thrombosis<br>Additionally for Microcurrent, Interferential,<br>Premodulated (IFS), VMS, VMS Burst,<br>Asymmetrical Biphasic (TENS) and<br>Symmetrical Biphasic (TENS):<br>- symptomatic relief and management of<br>chronic, intractable pain<br>- post-traumatic acute pain<br>- post-surgical acute pain<br>For FES:<br>Stimulation of the muscles in the leg and<br>ankle of partially paralyzed patients to<br>provide flexion of the foot and thus improve<br>the patient's gait.<br>For DC Continuous Mode:<br>- Relaxation of muscle spasm<br>For EMG:<br>To determination the activation timing of<br>muscles for a) retraining of muscle<br>activation b) coordination of muscle<br>activation An indication of the force<br>produced by muscle for control and<br>maintenance of muscle contractions.<br>Relaxation muscle training. Muscle re-<br>education<br>For EMG triggered Stim:<br>Stroke rehab by muscle re-education<br>-Relaxation of muscle spasm<br>-Prevention of retardation of disuse atrophy<br>-Increase local blood circulation<br>-Muscle re-education<br>-Maintaining or increase range of motion<br>For Ultrasound:<br>Application of therapeutic deep heat for the<br>treatment of selected sub-chronic and<br>chronic medical conditions such as:<br>-relief of pain, muscle spasms and joint<br>contractures<br>-relief of pain, muscle spasms and joint<br>contractures that may be associated with:<br>-adhesive capsulitis<br>-bursitis with slight calcification<br>-myositis<br>-soft tissue injuries<br>-shortened tendons due to past injuries<br>and scar tissues<br>-relief of sub-chronic, chronic pain and<br>joint contractures resulting from:<br>-capsular tightness<br>-capsular scarring | Vectra Genisys (Intelect XT)<br>Laser Module and Vectra<br>Genisys (Intele<br>XT) Laser Transportable<br>Systems are indicated for<br>topical heating for:<br>-temporary increase in local<br>blood circulation<br>-temporary relief of minor<br>muscle and joint aches,<br>pains, and stiffness<br>-relaxation of muscles<br>-temporary relief of muscle<br>spasms<br>-temporary relief of minor<br>pain and stiffness<br>associated with arthritis |

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Image /page/9/Picture/0 description: The image shows a blue logo with the letters BTL inside of three diamond shapes. The diamond shapes are connected to each other. The logo is simple and modern. The color blue is a calming and professional color.

| Device Name | BTL-4000 | Vectra Genisys | Vectra Genisys Laser<br>System |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | BTL Industries, Inc. | Chattanooga Medical Supply, Inc. | Chattanooga Medical<br>Supply, Inc. |
| 510(k) Number | Current submission | K031077 | K040662 |
| Product Code | GZI<br>GZJ<br>ILY<br>IMG<br>IPF<br>LIH | GZI<br>GZJ<br>IMG<br>IPF<br>нсс<br>LIH | ILY |
| Electrical<br>Protection | Class II, BF | Class I, BF | Class I, B |
| Dimensions | 380×190×260 mm | 289×222×324 mm | 288mm(with applicator) /<br>239mm(without<br>applicator)×163mm×328mm |
| Power Voltage and<br>Frequency | ~ 100 V to 240 V AC, 50-60 Hz | ~ 100 V to 240 V AC, 50-60 Hz | ~ 100 V to 240 V AC, 50-<br>60 Hz |
| Covering Grade | IP20 | IPX0 | unknown |
| Display | colour, touchscreen | colour, display | |
| Trolley available | yes | yes | yes |
| Body areas<br>Indication | yes | yes | yes |
| Battery module | optional | optional | yes |
| Operating<br>Conditions | 10 °C to +30 °C<br>30 % to 75 %<br>700 hPa to 1,060 hPa | 100-240 V - 1.0 A, 50/60 Hz | 10 °C to +30 °C<br>30 % to 75 %<br>700 hPa to 1,060 hPa |
| Electrotherapy Module | | | |
| Electrical<br>protection | BF | BF | N/A |
| Number of<br>channels | 2; 4 | 2; 4 | N/A |
| Output Intensity | 0-500 V, 0-200 mA | 0-500 V, 0-200 mA | N/A |
| Electrotherapy<br>Currents | IFC - Interferential (Traditional 4 Pole)<br>Premodulated (Traditional 2 Pole IFC)<br>TENS - Symmetrical Biphasic<br>TENS - Asymmetrical Biphasic<br>Russian<br>Direct Current<br>Microcurrent<br>High Voltage Pulsed Current (HVPC)<br>VMS. VMS Burst | IFC - Interferential (Traditional 4 Pole)<br>Premodulated (Traditional 2 Pole IFC)<br>TENS - Symmetrical Biphasic<br>TENS - Asymmetrical Biphasic<br>Russian<br>Direct Current<br>Microcurrent<br>High Voltage Pulsed Current (HVPC)<br>VMS. VMS Burst | N/A |
| EMG<br>(Biofeedback) | no | yes | N/A |
| TENS - asymmetrical biphasic | | | |
| Intensity - CC<br>Mode | 0-110 mA | 0–110 mA | N/A |
| Intensity - CV<br>mode | 0-110 V | 0-110 V | N/A |
| Maximum Phase<br>Duration | 20-1000 us | 20-1000 us | N/A |
| Frequency Range | 1–250 Hz | 0–250 Hz | N/A |
| Device Name | BTL-4000 | Vectra Genisys | Vectra Genisys Laser<br>System |
| Manufacturer | BTL Industries, Inc. | Chattanooga Medical Supply, Inc. | Chattanooga Medical<br>Supply, Inc. |
| 510(k) Number | Current submission | K031077 | K040662 |
| Maximum Average<br>Power Density | Electrode 7.5×14 cm -> 0.05 W/cm2<br>Electrode 3.2 cm -> 0.62 W/cm-<br>Electrode 5 cm -> 0.25 W/cm2 | | N/A |
| Current Density | Depends on the surface of the chosen<br>electrode 0.1-14 mA/cm- | Depends on the surface of the chosen<br>electrode 0.1-16 mA/cm- | N/A |
| Waveform Shape | | | N/A |
| Electrode Size | 7.5×14 cm<br>3.2 cm<br>5 cm | 3 cm<br>7 cm | N/A |
| Number of<br>Channels | 2 | 2 | N/A |
| Channel Isolation | 1 MOPP (1500 V) | - | N/A |
| TENS - symmetrical biphasic | | | |
| Intensity - CC<br>Mode | 0-80 mA | 0-80 mA | N/A |
| Intensity - CV<br>mode | 0-80 V | 0–80 V | N/A |
| Maximum Phase<br>Duration | 20-1000 us | 20-1000 us | N/A |
| Frequency Range | 1–250 Hz | 1–250 Hz | N/A |
| Maximum Average<br>Power Density | Electrode 7.5×14 cm -> 0.05 W/cm2<br>Electrode 3.2 cm -> 0.62 W/cm2<br>Electrode 5 cm -> 0.25 W/cm2 |…