(97 days)
Not Found
No
The summary describes a non-invasive therapeutic device that delivers electromagnetic energy for muscle stimulation. It mentions a touch screen interface for setting parameters and guiding the user, but there is no mention of AI, ML, or any data processing or analysis that would indicate the use of such technologies. The performance studies focus on electrical safety and compliance with standards, not on algorithmic performance.
Yes
The Device Description explicitly states, "The BTL-899M is a non-invasive therapeutic device." Additionally, the Intended Use section indicates it is for "adjunctive therapy for the treatment of medical diseases and conditions" and for "rehabilitative purposes."
No
Explanation: The device is described as a "non-invasive therapeutic device" intended for "adjunctive therapy for the treatment of medical diseases and conditions" and "stimulating neuromuscular tissue for bulk muscle excitation for rehabilitative purposes." Its listed indications for use are all therapeutic (e.g., relaxation of muscle spasms, prevention of disuse atrophy), not diagnostic.
No
The device description explicitly states it is comprised of a "main unit and an applicator that deliver electromagnetic energy" and mentions hardware components like a "large color touch-screen." This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, the BTL-899M device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe a therapeutic device that applies electromagnetic energy to the patient's body for the treatment of medical conditions and rehabilitation. This involves direct interaction with the patient's tissues.
- Device Description: The description details a non-invasive therapeutic device that delivers energy to targeted tissue via an applicator. This is consistent with a physical therapy or medical treatment device, not a device that analyzes samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to stimulate neuromuscular tissue.
- Performance Studies: The performance studies focus on electrical safety and compliance with standards related to medical electrical equipment and usability, which are typical for therapeutic devices, not IVDs. The absence of clinical testing is also consistent with a device that relies on established physical principles for its therapeutic effect, rather than a diagnostic device requiring clinical validation of its analytical performance.
- Predicate Device: The predicate device (HPM-6000) is also likely a similar type of therapeutic device, further supporting the conclusion that the BTL-899M is not an IVD.
In summary, the BTL-899M is a therapeutic device used for physical treatment, not a device used to diagnose conditions by analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The BTL-899M device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The BTL-899M device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.
Indications for Use for Muscle Stimulators:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
Product codes (comma separated list FDA assigned to the subject device)
IPF
Device Description
The BTL-899M is a non-invasive therapeutic device. The device is comprised of a main unit and an applicator that deliver electromagnetic energy to the targeted tissue. The device's output enables handsfree treatment.
The application of electromagnetic energy to the patient's feeling of magnetic stimulation of underlying muscles, joints and connective tissue accompanied by a pleasant feeling of warming sensation in the application area, which may contribute to increased local blood circulation and help the patient to relax and make the treatment more comfortable.
The BTL-899M is equipped with a large color touch-screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy, the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
legs or arms
Indicated Patient Age Range
Not Found
Intended User / Care Setting
under medical supervision
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 (Performance, Bench Testing):
The BTL-899M device has been thoroughly evaluated for electrical safety. The device has been found to comply with the following applicable medical device safety standards:
- IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility – Requirements and tests
- IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
- IEC 62304 Medical device software - Software life cycle processes
- ISO 14971 Medical devices – Application of risk management to medical devices
- ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Clinical Testing: Not applicable
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
§ 890.5850 Powered muscle stimulator.
(a)
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.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
December 26, 2023
BTL Industries, Inc David Chmel Official Correspondent 362 Elm Street Marlborough, Massachusetts 01752
Re: K232937
Trade/Device Name: BTL-899M Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: November 27, 2023 Received: November 27, 2023
Dear David Chmel:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Heather L. Dean -S
for CDR Jitendra Virani, MS, MBA Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232937
Device Name BTL-899M
Indications for Use (Describe)
The BTL-899M device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The BTL-899M device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.
Indications for Use for Muscle Stimulators:
- · Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- · Maintaining or increasing range of motion
| 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) |
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Image /page/4/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares that are nested inside of each other. To the right of the squares is the text "BTL Industries" in a gray sans-serif font.
510(k) Summary
K232937
General Information
| Sponsor: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
| Contact Person: | David Chmel
BTL Industries, Inc.
chmel@btlnet.com |
| Summary Preparation
Date: | 21 December 2023 |
Device Name
| Trade/Proprietary Name: | BTL-899M |
|---|---|
| Regulation Number: | 21 CFR 890.5850 |
| Regulation Name: | Powered Muscle Stimulator |
| Regulatory Class: | Class II |
| Product Code: | IPF |
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Image /page/5/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of two parts: a geometric symbol on the left and the text "BTL Industries" on the right. The geometric symbol is made up of three nested squares, each rotated 45 degrees, and the letters "BTL" are placed inside the innermost square. The text "BTL Industries" is written in a sans-serif font and is gray in color.
Legally Marketed Predicate Device
The BTL-899M is a state-of-the-art device with accessories using the electromagnetic energy for therapeutic purposes and is substantially equivalent to the current product that is already cleared for distribution in the USA under the following 510(k) Premarket Notification number:
- HPM-6000 (K160992)
Product Description
The BTL-899M is a non-invasive therapeutic device. The device is comprised of a main unit and an applicator that deliver electromagnetic energy to the targeted tissue. The device's output enables handsfree treatment.
The application of electromagnetic energy to the patient's feeling of magnetic stimulation of underlying muscles, joints and connective tissue accompanied by a pleasant feeling of warming sensation in the application area, which may contribute to increased local blood circulation and help the patient to relax and make the treatment more comfortable.
The BTL-899M is equipped with a large color touch-screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy, the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
Indications for Use
The BTL-899M device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The BTL-899M device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.
Indications for Use for Muscle Stimulators:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation ●
- . Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
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Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares on the left side, with the letters "BTL" inside the innermost square. To the right of the squares is the text "BTL Industries" in a sans-serif font. The logo is in a dark blue color.
Non-clinical Testing (Performance, Bench Testing)
The BTL-899M device has been thoroughly evaluated for electrical safety. The device has been found to comply with the following applicable medical device safety standards:
| IEC 60601-1 | Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromagnetic compatibility
– Requirements and tests |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basic safety
and essential performance – Collateral standard: Usability |
| IEC 62304 | Medical device software - Software life cycle processes |
| ISO 14971 | Medical devices – Application of risk management to medical devices |
| ISO 10993-1 | Biological evaluation of medical devices – Part 1: Evaluation and testing within
a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin
sensitization |
Clinical Testing
Not applicable
Technological Characteristics
The BTL-899M device has the same intended use and identical technological characteristics and principles of operation to its predicate device. The BTL-899M device and its predicate are comprised of a system console and an applicator. The system console consists of the generators, computer, and the touch-screen control panel.
The mechanism of action and technological similarities and differences between the BTL-899M device and the predicate device are described below in the comparison table. The differences do not raise any new types of safety or effectiveness questions.
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Image /page/7/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three overlapping squares with the letters B, T, and L inside them. The text "BTL Industries" is written to the right of the logo in a sans-serif font.
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Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares nested inside each other, with the letters "BTL" inside the innermost square. To the right of the logo is the text "BTL Industries" in a gray sans-serif font.
Comparison with the Predicate Device
| 510(k) number | K232937 | K160992 |
|---|---|---|
| Device name | BTL-899M | HPM-6000 |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. |
| Product Code | ||
| and Regulation | Physical Medicine | |
| 21 CFR 890.5850 | ||
| IPF - Stimulator, Muscle, Powered | Physical Medicine | |
| 21 CFR 890.5850 | ||
| IPF - Stimulator, Muscle, Powered | ||
| Indications for Use | The BTL-899M device is intended to | |
| be used under medical supervision for | ||
| adjunctive therapy for the treatment of | ||
| medical diseases and conditions. | ||
| The BTL-899M device is indicated for | ||
| use in stimulating neuromuscular | ||
| tissue for bulk muscle excitation in the | ||
| legs or arms for rehabilitative | ||
| purposes. | ||
| Indications for Use for Muscle | ||
| Stimulators: | ||
| • Relaxation of muscle spasms | ||
| • Prevention or retardation of disuse | ||
| atrophy | ||
| • Increasing local blood circulation | ||
| • Muscle re-education | ||
| • Immediate post-surgical stimulation | ||
| of calf muscles to prevent venous | ||
| thrombosis | ||
| • Maintaining or increasing range of | ||
| motion | The HPM-6000 device is intended to | |
| be used under medical supervision for | ||
| adjunctive therapy for the treatment of | ||
| medical diseases and conditions. | ||
| The HPM-6000 device is indicated for | ||
| use in stimulating neuromuscular | ||
| tissue for bulk muscle excitation in the | ||
| legs or arms for rehabilitative | ||
| purposes. | ||
| Indications for Use for Muscle | ||
| Stimulators: | ||
| • Relaxation of muscle spasms | ||
| • Prevention or retardation of disuse | ||
| atrophy | ||
| • Increasing local blood circulation | ||
| • Muscle re-education | ||
| • Immediate post-surgical stimulation | ||
| of calf muscles to prevent venous | ||
| thrombosis | ||
| • Maintaining or increasing range of | ||
| motion | ||
| Electrical Protection | Class II, BF | Class II, BF |
| Interface | Touch screen | Touch-screen |
| Type of Energy | Electromagnetic energy for magnetic | |
| stimulation and application of warming | ||
| sensation through radiofrequency | Magnetic field | |
| Type of Applicator | Single magnetic coil | Single magnetic coil |
| Number of Magnetic | ||
| coils in the | ||
| Applicators | 1 | 1 |
| Number of | ||
| Applicators | 1 | 2 |
| Color Touch Screen | 15.6 in | |
| 39.6 cm | ||
| 1920 x 1080 px. | 8.4 in | |
| 21.3 cm | ||
| 800x400 pixel | ||
| Type of Operation | Continuous | Continuous |
| Pulse Repetition | ||
| Rate - supported by | ||
| the device | 1 - 150 Hz | 1-150 Hz |
| Magnetic Field | ||
| Intensity | AP-C-1 - 0.5 to 1.8 T | 299-1 applicator: 0.5-1.8 T |
| 299-2 applicator: 0.7-2.5 T | ||
| Pulse Duration | AP-C-1 - 280 µs ± 20% | 299-1 applicator: 280 µs ± 20% |
| 299-2 applicator: 280 µs ± 20% | ||
| Pulse Amplitude | 0–100 % | 0-100 % |
| Shape of | ||
| Stimulation Pulse | Sine, biphasic | Sine, biphasic |
| RF Type | bipolar | N/A |
| Max. RF Power | 30 W | N/A |
| RF Frequency | 27.12 Mhz | N/A |
| Temperature Sensor | Yes | N/A |
| Therapy Time | Up to 30 min | Up to 60 min |
| Application | Hands-free, applicator fixed by fixation | |
| belt | Hands-free, applicator fixed in application | |
| arm | ||
| External | ||
| Exchangeable Fuse | Yes | Yes |
| Energy Source | 100 - 240 V AC, 50-60 Hz | 100 - 240 V AC, 50-60 Hz |
| System Dimensions | ||
| ( $W×H×D$ ) | 23 x 39 x 29 in | |
| (592 x 985 x 730 mm) | 20×38×23 in | |
| (500 x 970 x 580 mm) | ||
| System Weight | 70 kg | 33 kg |
| Operating Ambient | ||
| Temperature | +10°C to +30°C | +10°C to +30°C |
| Operating Relative | ||
| Humidity | 30% to 75% | 30% to 75% |
| Environmental | ||
| Specifications | For indoor use only | |
| In vertical position - On castors | For indoor use only | |
| In vertical position - On castors |
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Image /page/9/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a blue geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three interlocking squares, each with the letters "BTL" inside. The text "BTL Industries" is written in a simple, sans-serif font.
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Image /page/10/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each containing the letters "BTL" inside. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.
Therapy Time
The subject device has a standard adjustable therapy duration of up to 30 minutes, which differs from the predicate device, which allows therapy to be set for up to 60 minutes. However, the device has the same output parameters as the predicate device in terms of maximum frequency, duty factor, maximum magnetic field intensity and pulse duration. If the operator deems it necessary to provide longer therapy to a patient, the subject device can be used repeatedly and the final dosage of energy delivered per the same time will be the same as for the predicate device. Therefore, this difference does not raise any unacceptable risks or unacceptable questions in relation to safety or efficacy.
Number of applicators
The applicator AP-C-1 is intended to be used with the subject device to achieve the intended purpose whereas the predicate device allows the use of one of two available applicators 299-1 or 299-2 to achieve the intended purpose of the device. The AP-C-1 applicator intended to be used with the subject device has the same maximum output parameters in terms of maximum magnetic field intensity and pulse duration as the predicator 299-1. Therefore, this difference does not raise any unacceptable risks or unacceptable questions in relation to safety or efficacy.
Weight & Dimensions
These parameters do not have any significant effect on the efficiency or safety of the device.
Additional energy and its parameters
BTL-899M incorporates application of the warming sensation on subtherapeutic level (up to 40°C) at the patient application site to increase patient convenience, soothe, and relax them during therapy. This application of additional energy does not raise any unacceptable risks or questions related to safety or effectiveness.
Temperature sensor
BTL-899M incorporates application of the warming sensation on subtherapeutic level (up to 40°C) at the patient application site to increase patient convenience, soothe and relax them during therapy. Based on this additional energy presence, there is a temperature sensor to monitor and regulate this additional modality. This application of additional energy does not raise any unacceptable risks or questions related to safety or effectiveness.
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Image /page/11/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares on the left side of the image. The text "BTL Industries" is on the right side of the image in a sans-serif font.
Substantial Equivalence
The BTL-899M device has the same intended use as its predicate device. The technological characteristics of the predicate device are similar to the BTL-899M device. Any differences between the predicate device and BTL-899M have no significant influence on safety and effectiveness of the BTL-899M device. Therefore, the BTL-899M is substantially equivalent to the predicate device.
Conclusion
Based upon the intended use and the known technical and clinical data provided in this pre-market notification, the BTL-899M device has been shown to be substantially equivalent to the currently marketed predicate device.