(275 days)
Not Found
No
The description focuses on standard physiotherapy modalities (electrotherapy, ultrasound, laser) and a user interface for selecting protocols. There is no mention of AI, ML, or any features that suggest adaptive learning, pattern recognition, or data-driven decision-making beyond pre-programmed protocols.
Yes
The device description clearly states "BTL-4000 is a professional physiotherapy device," and its intended uses involve various therapeutic methods like electrotherapy, ultrasound therapy, and laser therapy for medical conditions such as pain relief, muscle spasms, and improved gait.
No
The document describes therapies (electrotherapy, ultrasound, laser) that provide treatment for various conditions, such as pain relief, muscle relaxation, and improved range of motion. It does not mention any diagnostic capabilities for identifying or assessing medical conditions.
No
The device description explicitly states that the BTL-4000 is a professional physiotherapy device that can consist of up to three generators (electrotherapy, ultrasound therapy, and laser therapy) and includes physical components like a control unit, user interface with touch screen, therapy modules, and accessories such as electrodes, laser probes, and ultrasound heads. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are all related to therapeutic interventions applied directly to the patient's body (electrotherapy, ultrasound therapy, laser therapy) for conditions like pain relief, muscle issues, and improving gait. IVDs are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description clearly states it's a "professional physiotherapy device" that applies electrical current, mechanical waves (ultrasound), and light (laser) to the patient. This aligns with therapeutic devices, not diagnostic ones that analyze biological samples.
- No mention of analyzing biological specimens: There is no mention of collecting or analyzing any type of biological sample from the patient.
Therefore, the BTL-4000 is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IMG, IPF, GZJ, GZI, LIH, ILY
Device 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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, IEC 62304, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-5, IEC 60601-2-10, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-6, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 14971, IEC 62304.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5860 Ultrasound and muscle stimulator.
(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)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.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/11 description: The image contains the logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which includes a stylized depiction of a human face in profile, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the emblem. The emblem is positioned to the right of the text.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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.
3
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4
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.
47 Loring Drive
Framingham, MA 01702
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
|------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.
47 Loring Drive
Framingham, MA 01702
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
- Contact Person: Jan Zarsky BTL Industries, Inc. Executive VP zarsky@btlnet.com
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
5
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
6
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
System |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | BTL Industries, Inc. | Chattanooga Medical Supply, Inc. | Chattanooga Medical
Supply, Inc. |
| 510(k) Number | Current submission | K031077 | K040662 |
| 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 - 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 Continuous Mode: - Relaxation of muscle spasm
For Laser:
the laser module is indicated for topical
heating for:
-temporary increase in 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
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
-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 | 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 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 spasm
-Prevention of retardation of disuse atrophy
-Increase local blood circulation
-Muscle re-education
-Maintaining or increase range of motion
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
-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 | Vectra Genisys (Intelect XT)
Laser Module and Vectra
Genisys (Intele
XT) Laser Transportable
Systems are indicated for
topical heating for:
-temporary increase in 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 |
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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
System |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | BTL Industries, Inc. | Chattanooga Medical Supply, Inc. | Chattanooga Medical
Supply, Inc. |
| 510(k) Number | Current submission | K031077 | K040662 |
| Product Code | GZI
GZJ
ILY
IMG
IPF
LIH | GZI
GZJ
IMG
IPF
нсс
LIH | ILY |
| Electrical
Protection | Class II, BF | Class I, BF | Class I, B |
| Dimensions | 380×190×260 mm | 289×222×324 mm | 288mm(with applicator) /
239mm(without
applicator)×163mm×328mm |
| Power Voltage and
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-
60 Hz |
| Covering Grade | IP20 | IPX0 | unknown |
| Display | colour, touchscreen | colour, display | |
| Trolley available | yes | yes | yes |
| Body areas
Indication | yes | yes | yes |
| Battery module | optional | optional | yes |
| Operating
Conditions | 10 °C to +30 °C
30 % to 75 %
700 hPa to 1,060 hPa | 100-240 V - 1.0 A, 50/60 Hz | 10 °C to +30 °C
30 % to 75 %
700 hPa to 1,060 hPa |
| Electrotherapy Module | | | |
| Electrical
protection | BF | BF | N/A |
| Number of
channels | 2; 4 | 2; 4 | N/A |
| Output Intensity | 0-500 V, 0-200 mA | 0-500 V, 0-200 mA | N/A |
| Electrotherapy
Currents | IFC - Interferential (Traditional 4 Pole)
Premodulated (Traditional 2 Pole IFC)
TENS - Symmetrical Biphasic
TENS - Asymmetrical Biphasic
Russian
Direct Current
Microcurrent
High Voltage Pulsed Current (HVPC)
VMS. VMS Burst | IFC - Interferential (Traditional 4 Pole)
Premodulated (Traditional 2 Pole IFC)
TENS - Symmetrical Biphasic
TENS - Asymmetrical Biphasic
Russian
Direct Current
Microcurrent
High Voltage Pulsed Current (HVPC)
VMS. VMS Burst | N/A |
| EMG
(Biofeedback) | no | yes | N/A |
| TENS - asymmetrical biphasic | | | |
| Intensity - CC
Mode | 0-110 mA | 0–110 mA | N/A |
| Intensity - CV
mode | 0-110 V | 0-110 V | N/A |
| Maximum Phase
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
System |
| Manufacturer | BTL Industries, Inc. | Chattanooga Medical Supply, Inc. | Chattanooga Medical
Supply, Inc. |
| 510(k) Number | Current submission | K031077 | K040662 |
| Maximum Average
Power Density | Electrode 7.5×14 cm -> 0.05 W/cm2
Electrode 3.2 cm -> 0.62 W/cm-
Electrode 5 cm -> 0.25 W/cm2 | | N/A |
| Current Density | Depends on the surface of the chosen
electrode 0.1-14 mA/cm- | Depends on the surface of the chosen
electrode 0.1-16 mA/cm- | N/A |
| Waveform Shape | | | N/A |
| Electrode Size | 7.5×14 cm
3.2 cm
5 cm | 3 cm
7 cm | N/A |
| Number of
Channels | 2 | 2 | N/A |
| Channel Isolation | 1 MOPP (1500 V) | - | N/A |
| TENS - symmetrical biphasic | | | |
| Intensity - CC
Mode | 0-80 mA | 0-80 mA | N/A |
| Intensity - CV
mode | 0-80 V | 0–80 V | N/A |
| Maximum Phase
Duration | 20-1000 us | 20-1000 us | N/A |
| Frequency Range | 1–250 Hz | 1–250 Hz | N/A |
| Maximum Average
Power Density | Electrode 7.5×14 cm -> 0.05 W/cm2
Electrode 3.2 cm -> 0.62 W/cm2
Electrode 5 cm -> 0.25 W/cm2 | | N/A |
| Current Density | Depends on the surface of the chosen
electrode 0.1-10 mA/cm- | Depends on the surface of the chosen
electrode 0.1-11.5 mA/cm- | N/A |
| Waveform Shape | | | N/A |
| Electrode Size | 7.5×14 cm
3.2 cm
5 cm | 3 cm
7 cm | N/A |
| Number of
Channels | 2 | 2 | N/A |
| Channel Isolation | 1 MOPP (1500 V) | - | N/A |
| IFC - Interferential | | | |
| Intensity - CC
Mode | 0-100 mA | 0-100 mA | N/A |
| Intensity - CV
mode | 0-100 V | 0-100 V | N/A |
| Maximum Phase
Duration | | | N/A |
| Frequency Range | Carrier->2500, 4000 and 5000 Hz
Beat (sweep off)->1-200 Hz
Sweep Low Beat Frequency->1-199 Hz
Sweep High Beat Frequency->1-200Hz | Carrier->2500, 4000 and 5000 Hz
Beat (sweep off)->1-200 Hz
Sweep Low Beat Frequency->1-199 Hz
Sweep High Beat Frequency->1-200 Hz | N/A |
| Maximum Average
Power Density | Electrode 7.5×14 cm→0.05 W/cm²
Electrode 3.2 cm->0.62 W/cm-
Electrode 5 cm->0.25 W/cm2 | | N/A |
| Current Density | Depends on the surface of the chosen
electrode 0.1-12.5 mA/cm- | Depends on the surface of the chosen
electrode 0.1-14 mA/cm- | N/A |
| Waveform Shape | | | N/A |
| Electrode Size | 7.5×14 cm
3.2 cm
5 cm | 3 cm
7 cm | N/A |
| Number of
Channels | 2 | 2 | N/A |
| Channel Isolation | 1 MOPP (1500 V) | - | N/A |
| Device Name | BTL-4000 | Vectra Genisys | Vectra Genisys Laser
System |
| Manufacturer | BTL Industries, Inc. | Chattanooga Medical Supply, Inc. | Chattanooga Medical
Supply, Inc. |
| 510(k) Number | Current submission | K031077 | K040662 |
| Premodulated (2-pole Interference) | | | |
| Intensity - CC
Mode | 0-100 mA | 0-100 mA | N/A |
| Intensity - CV
mode | 0–100 V | 0-100 V | N/A |
| Maximum Phase
Duration | - | - | N/A |
| Frequency Range | Carrier→2500 Hz
Beat (sweep off)→1-200 Hz
Sweep Low Beat Frequency→1-199Hz
Sweep High Beat Frequency→2-200Hz | Carrier→2500 Hz
Beat (sweep off)→1-200 Hz
Sweep Low Beat Frequency→1-199Hz
Sweep High Beat Frequency→2-200Hz | N/A |
| Maximum Average
Power Density | Electrode 7.5×14 cm→0.05 W/cm²
Electrode 3.2 cm→0.62 W/cm²
Electrode 5 cm→0.25 W/cm² | - | N/A |
| Current Density | 0.1-12.5 mA/cm² | 0.1-14 mA/cm² | N/A |
| Waveform Shape | Image: [waveform] | Image: [waveform] | N/A |
| Electrode Size | 7.5×14 cm
3.2 cm
5 cm | 3 cm
7 cm | N/A |
| Number of
Channels | 2 | 2 | N/A |
| Channel Isolation | 1 MOPP (1500 V) | - | N/A |
| Russian Stimulation | | | |
| Intensity - CC
Mode | 0-100 mA | 0-100 mA | N/A |
| Intensity - CV
mode | 0–100 V | 0–100 V | N/A |
| Maximum Phase
Duration | - | - | N/A |
| Frequency Range | Carrier→2500 Hz
Burst frequency→20-100 bps | Carrier→2500 Hz
Burst frequency→20-100 bps | N/A |
| Maximum Average
Power Density | Electrode 7.5×14 cm→0.05 W/cm²
Electrode 3.2 cm→0.62 W/cm²
Electrode 5 cm→0.25 W/cm² | - | N/A |
| Current Density | 0.1-12.5 mA/cm² | 0.1-14 mA/cm² | N/A |
| Waveform Shape | Image: [waveform] | Image: [waveform] | N/A |
| Electrode Size | 7.5×14 cm
3.2 cm
5 cm | 3 cm
7 cm | N/A |
| Number of
Channels | 2 | 2 | N/A |
| Channel Isolation | 1 MOPP (1500 V) | - | N/A |
| Direct Current | | | |
| Intensity - CC
Mode | 0–4 mA | 0-4 mA | N/A |
| Intensity - CV
mode | - | - | N/A |
| Maximum Phase
Duration | - | - | N/A |
| Frequency Range | - | - | N/A |
| Maximum Average
Power Density | Electrode 7.5×14 cm→0.05 W/cm²
Electrode 3.2 cm→0.62 W/cm²
Electrode 5 cm→0.25 W/cm² | - | N/A |
| Device Name | BTL-4000 | Vectra Genisys | Vectra Genisys Laser
System |
| Manufacturer | BTL Industries, Inc. | Chattanooga Medical Supply, Inc. | Chattanooga Medical
Supply, Inc. |
| 510(k) Number | Current submission | K031077 | K040662 |
| Waveform Shape | | | N/A |
| Electrode Size | 7.5×14 cm
3.2 cm
5 cm | 3 cm
7 cm | N/A |
| Number of
Channels | 2 | 2 | N/A |
| Channel Isolation | 1 MOPP (1500 V) | - | N/A |
| Microcurrents | | | |
| Intensity - CC
Mode | 5-1000 µA | 5-1000 µA | N/A |
| Intensity - CV
mode | | | N/A |
| Maximum Phase
Duration | 0-1 s | | N/A |
| Frequency Range | Carrier->0.1-1000 Hz | Carrier->0.1-1000 Hz | N/A |
| Maximum Average
Power Density | Electrode 7.5×14 cm->0.05 W/cm2
Electrode 3.2 cm->0.62 W/cm2
Electrode 5 cm->0.25 W/cm2 | - | N/A |
| Current Density | 0-0.12 mA/cm- | 0-0.14 mA/cm² | N/A |
| Waveform Shape | | | N/A |
| Electrode Size | 7.5×14 cm
3.2 cm
5 cm | 3 cm
7 cm | N/A |
| Number of
Channels | 2 | 2 | N/A |
| Channel Isolation | 1 MOPP (1500 V) | - | N/A |
| | High Voltage Pulsed Current (HVPC) | | |
| Intensity - CC
Mode | | | N/A |
| Intensity - CV
mode | 0-500 V | 0–200 V | N/A |
| Maximum Phase
Duration | 50 hs | | N/A |
| Frequency Range | 10-120 pps | 10-120 pps | N/A |
| Maximum Average
Power Density | Electrode 7.5×14 cm->0.05 W/cm2
Electrode 3.2 cm->0.62 W/cm2
Electrode 5 cm→0.25 W/cm² | | N/A |
| Waveform Shape | P | | N/A |
| Electrode Size | 7.5×14 cm
3.2 cm
5 cm | 3 cm
7 cm | N/A |
| Number of
Channels | 2 | 2 | N/A |
| Channel Isolation | 1 MOPP (1500V) | - | N/A |
| VMS, VMS Burst | | | |
| Intensity - CC
Mode | 0-200 mA | 0–200 mA | N/A |
| Intensity - CV
mode | 0-200 V | 0–200 V | N/A |
| Maximum Phase
Duration | 20-400 µs | 20-400 us | N/A |
| Frequency Range | 1–200 Hz | 1–200 Hz | N/A |
| Maximum Average
Power Density | Electrode 7.5×14 cm→0.05 W/cm²
Electrode 3.2 cm->0.62 W/cm2
Electrode 5 cm->0.25 W/cm2 | | N/A |
| Current Density | 0.1-25 mA/cm2 | 0.1-30 mA/cm2 | N/A |
| Waveform Shape | | | N/A |
| Device Name | BTL-4000 | Vectra Genisys | Vectra Genisys Laser
System |
| Manufacturer | BTL Industries, Inc. | Chattanooga Medical Supply, Inc. | Chattanooga Medical
Supply, Inc. |
| 510(k) Number | Current submission | K031077 | K040662 |
| Electrode Size | $7.5\times14$ cm
$3.2$ cm
$5$ cm | $3$ cm
$7$ cm | N/A |
| Number of
Channels | $2$ | $2$ | N/A |
| Channel Isolation | 1 MOPP ( $1500$ V) | - | N/A |
| Laser Module | | | |
| Electrical
protection | BF | N/A | B |
| Frequency | $8$ - $10000$ Hz and continuous | N/A | $8$ - $10000$ Hz and continuous |
| Type of
applicators | probe, cluster | N/A | probe, cluster |
| Laser applicators
models | Probe $830$ nm/ $50$ mW
Probe $830$ nm/ $100$ mW
Probe $830$ nm/ $200$ mW
Probe $830$ nm/ $300$ mW
Laser cluster $\rightarrow$ $685$ nm/ $200$ mW
Laser cluster $\rightarrow$ $830$ nm/ $800$ mW
Laser cluster $\rightarrow$ $830$ nm/ $1300$ mW
Combined cluster $\rightarrow$ $685$ nm,
$830$ nm/ $1000$ mW
Combined cluster $\rightarrow$ $685$ nm,
$830$ nm/ $1500$ mW | N/A | $850$ nm/ $100$ mW
$850$ nm/ $150$ mW
$850$ nm/ $200$ mW
$820$ nm/ $300$ mW
$670$ nm, $950$ nm Cluster $540$
mW
$670$ nm, $950$ nm Cluster
$1040$ mW
$670$ nm, $850$ nm, $950$ nm
Cluster $415$ mW
$670$ nm, $850$ nm, $950$ nm
Cluster $715$ mW
$670$ nm, $850$ nm, $880$ nm,
$950$ nm Cluster $1440$ mW |
| Applicators | single diode applicator $0.0314$ cm2
cluster $25$ cm2 | N/A | single diode applicator
$0.07$ - $0.495$ cm2
cluster $7.55$ - $31.2$ cm2 |
| Output Power | $5$ - $1500$ mW (dependent on applicator) | N/A | $100$ - $1440$ mW (dependent
on applicator) ( $\pm 20$ %) |
| Duty cycle setting | yes | N/A | yes |
| Wavelength | $685$ - $830$ nm ( $\pm 20$ %) | N/A | $670$ - $950$ nm |
| | | Ultrasound Module | |
| Electrical
Protection | Class II, BF | Class I, B | N/A |
| Intensity -
Continuous Mode | $0.1$ - $2$ W/cm2 ( $\pm 30$ %) | $0$ – $2.5$ W/cm2 | N/A |
| Intensity - Pulsed
Mode | $0.1$ - $3$ W/cm2 ( $\pm 30$ %) | $0$ - $3$ W/cm2 | N/A |
| Frequency | $1$ MHz ( $\pm 5$ %) | $1$ MHz ( $\pm 5$ %) | N/A |
| | $3.1$ MHz ( $\pm 5$ %) | $3.3$ MHz ( $\pm 5$ %) | N/A |
| Duty Cycle | $6.25$ - $100$ % ( $\pm 30$ %) | $10$ %, $20$ %, $50$ %, Continuous | N/A |
| Pulse Frequency | $10$ — $100$ Hz | $100$ Hz | N/A |
| Ultrasound Heads | $1$ cm2, $5$ cm2, Handsfree Sono $4$ ,
Handsfree Sono $6$ | $1$ cm2, $2$ cm2, $5$ cm2, $10$ cm2 | N/A |
| Applicator Size
$1$ cm2 Head | Crystal diameter – $1.25$ cm
Surface - $1.5$ cm2 | $1$ cm2 | N/A |
| Applicator Size
$5$ cm2 Head | Crystal diameter – $2.5$ cm
Surface – $7.9$ cm2 | $5$ cm2 | N/A |
| Applicator Size
Handsfree Sono $4$ | Crystal - $3\times1.4$ cm
Surface of the applicator - $31.5$ cm2 | - | N/A |
| Device Name | BTL-4000 | Vectra Genisys | Vectra Genisys Laser
System |
| Manufacturer | BTL Industries, Inc. | Chattanooga Medical Supply, Inc. | Chattanooga Medical
Supply, Inc. |
| 510(k) Number | Current submission | K031077 | K040662 |
| Applicator Size
Handsfree Sono 6 | Crystal - 2.4×1.7 cm
Surface of the applicator - 31.5 cm2 | - | N/A |
| Applicator Size
2 cm2 Head | - | 2 cm2 | N/A |
| Applicator Size
10 cm2 Head | - | 10 cm2 | N/A |
| Crystal Material | • USN 1 cm2→Pz26
• USN 5 cm2→Pz26
• HandsFree 4→piezoceramic NCE41
• HandsFree 6→piezoceramic NCE41 | - | N/A |
| Beam Type | collimated
1 cm2 head→1MHz divergent beam | collimated | N/A |
| Temporal Max
Power for Pulsed
Mode | • USN 1 cm2→2.7 W ±20 %
• USN 5 cm2→13.2 W ±20 %
• HandsFree 4→12.3 W ±20 %
• HandsFree 6→12.3 W ±20 % | • USN 1 cm2→3 W ±20 %
• USN 2 cm2→6 W ±20 %
• USN 5 cm2→15 W ±20 %
• USN 10 cm2→30 W ±20 % | N/A |
| Temporal Average
Power for
Continuous Mode | • USN 1 cm2→1.8 W ±20 %
• USN 5 cm2→8.8 W ±20 %
• HandsFree 4→8.2 W ±20 %
• HandsFree 6→8.2 W ±20 % | • USN 1 cm2→2.5 W ±20 %
• USN 2 cm2→5 W ±20 %
• USN 5 cm2→7.5 W ±20 %
• USN 10 cm2→25 W ±20 % | N/A |
| Instantaneous
Peak Power | • USN 1 cm2→2.7 W ±20 %
• USN 5 cm2→13.2 W ±20 %
• HandsFree 4→12.3 W ±20 %
• HandsFree 6→12.3 W ±20 % | • USN 1 cm2→3 W ±20 %
• USN 2 cm2→6 W ±20 %
• USN 5 cm2→15 W ±20 %
• USN 10 cm2→30 W ±20 % | N/A |
| Temporal Max
Effective Intensity,
peak P/ERA | 3 W/cm2 ±30 % | 3 W/cm2 ±20 % | N/A |
| Temporal Average
Intensity | 0.1-2 W/cm2 ±30 % for the
output
intensity higher than 0.2 W/cm2 | 0.1-2 W/cm2 ±20 % | N/A |
| Temporal Peak to
Average Ratio
(Rtpa) for Pulsed
Mode | 16:1; 8:1; 4:1; 2:1; 1:1 | 2:1 ±20% at 50% duty cycle
5:1 ±20% at 20% duty cycle
10:1 ±20% at 10% duty cycle | N/A |
| Error
Uncertainties for
the Ultrasonic
Frequency | ±5 % | ±5 % | N/A |
| Effective radiating
Area and
Accuracy
(Beam Cross
Section) | • USN 1 cm2→0.9 cm2 ±20 %
• USN 5 cm2→4.4 cm2 ±20 %
• HandsFree 4→4×4.1 cm2 ±20 %
• HandsFree 6→6×4.1 cm2 ±20 % | • USN 1 cm2→0.7-1 cm2
• USN 2 cm2→1.4-2 cm2
• USN 5 cm2→3.5-5 cm2
• USN 10 cm2→6.8-10 cm2 | N/A |
| HandsFree Sono
Applicators | • Applicator mode - circular/random
(switching between crystals)
• Switching period - 0.3 s/0.5 s/0.7 s
• Application area -
activation/deactivation of crystal pairs
(at least one pair)
(for safety reasons when you choose one
pair of crystals the switching period is
fixed to 0.3 s) | N/A | N/A |
| Covering Grade | IP67 | IPX7 | N/A |
| Contact
Monitoring | yes | yes | N/A |
| Head Preheating | yes | yes | N/A |
10
Image /page/10/Picture/0 description: The image shows a logo with the letters B, T, and L. The letters are in blue and are connected to each other. The logo is made up of three diamond shapes, with each letter inside one of the diamonds. The logo is simple and modern.
11
Image /page/11/Picture/0 description: The image shows a logo with three interconnected blue diamonds. The letters "B", "T", and "L" are inscribed within each diamond, respectively. The logo has a clean and modern design.
12
Image /page/12/Picture/0 description: The image shows a blue logo with the letters B, T, and L. The letters are inside of three diamond shapes that are linked together. The diamond shapes are all the same size and are evenly spaced apart. The logo is simple and modern.
13
Image /page/13/Picture/0 description: The image shows a logo with the letters B, T, and L. The letters are in blue and are inside of three diamond shapes. The diamond shapes are connected to each other. The logo is simple and modern.
14
Image /page/14/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 used throughout the logo.
15
Image /page/15/Picture/0 description: The image shows a logo with three interconnected blue diamonds. The letters "BTL" are arranged within the diamonds, with "B" in the left diamond, "T" in the center diamond, and "L" in the right diamond. The logo has a clean and modern design.
Substantial Equivalence
Based upon the intended use and technical information provided in this pre-market notification, the BTL-4000 device has been shown to be substantially equivalent to currently marketed predicate devices.
Conclusion
Based on the aforementioned information, the BTL-4000 is safe and effective and substantially equivalent to the identified predicate devices.