(323 days)
BTL-703-2 is indicated to be used for:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- · Strengthening, toning and firming of buttocks, thighs and calves.
- · Improvement of muscle tone and firmness, for strengthening muscles in arms.
The BTL-703-2 is a non-invasive therapeutic device is comprised of a main unit and applicators that deliver electromagnetic and radiofrequency to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators.
The BTL-703-2 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 keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
The provided text is a 510(k) summary for the BTL-703-2 device. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and intended use. It does not typically contain detailed acceptance criteria and studies proving the device meets those criteria in the way described in your request for a medical AI/ML device.
Here's why and what information can be extracted:
- Acceptance Criteria & Performance: The document provides a comparison of technical characteristics between the proposed device (BTL-703-2) and its predicate (BTL 799-2L), as well as a reference device (BTL-899) for the radiofrequency component. These are not performance metrics in the sense of accuracy, sensitivity, or specificity that would be found in an AI/ML study. Instead, they are specifications related to the physical operation of the device (e.g., magnetic field intensity, pulse repetition rate, RF power). The "performance" here is simply that the device operates within these specified parameters, which is implicitly proven through non-clinical testing for electrical safety and electromagnetic compatibility.
- Study Design (implicitly): The document mentions "Non-clinical Testing" for electrical safety (IEC 60601-1, IEC 60601-1-2), software lifecycle processes (IEC 62304), risk management (ISO 14971), and biological evaluation (ISO 10993-1, -5, -10). These are standards compliance tests, not clinical efficacy studies with ground truth established by experts.
Therefore, many parts of your request (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, effect size, standalone performance, training set details) are not applicable to the information provided in this 510(k) summary. This document is not evaluating an AI/ML diagnostic or prognostic device.
Here's what can be extracted based on the provided text, structured as closely as possible to your request, with explanations for missing/non-applicable components:
Acceptance Criteria and Study for BTL-703-2 (Powered Muscle Stimulator)
This device, BTL-703-2, is a powered muscle stimulator cleared under a 510(k) pathway, demonstrating substantial equivalence to a predicate device. The "acceptance criteria" in this context are primarily related to safety, electrical compatibility, and performance characteristics compared to the predicate, rather than diagnostic accuracy or human performance improvement as would be relevant for an AI/ML device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Design Goal | Reported Device Performance / Compliance |
|---|---|---|
| Intended Use | Indications for Use: Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen; Strengthening, toning and firming of buttocks, thighs and calves; Improvement of muscle tone and firmness, for strengthening muscles in arms. | Identical to predicate device (BTL 799-2L) indications for use. |
| Core Technology | Utilize Electromagnetic stimulation for muscle stimulation. | The BTL-703-2 utilizes electromagnetic stimulation, identical to the predicate device BTL 799-2L. |
| Ancillary Technology | Incorporate bipolar radiofrequency for applicator warming to enhance patient comfort. | The device includes a bipolar radiofrequency generator to warm applicators to below 40°C. This technology has been cleared in other FDA devices (e.g., BTL-899, K192224). The differences do not raise new safety or effectiveness questions. |
| Basic Technology (Comparison w/ Predicate) | Electromagnetic stimulation accompanied by bipolar radiofrequency. | BTL-703-2: Electromagnetic stimulation accompanied by bipolar radiofrequency. Predicate (BTL 799-2L): Electromagnetic stimulation. Reference (BTL-899): Electromagnetic stimulation accompanied by bipolar radiofrequency. Conclusion: "Not Significantly different" - the addition of RF is for comfort, not primary therapeutic effect, and is equivalent to the reference device. |
| Electrical Protection | Class II, BF | Class II, BF (Same as predicate) |
| User Interface | Touch screen | Touch screen (Same as predicate) |
| Magnetic Field Intensity (on coil surface) | For app: BTL-899-AP-C-1: 0.5 to 1.8 TFor app: BTL-899-AP-C-2: 0.7 to 2.0 T | BTL-703-2: 0.5 to 1.8 T (BTL-899-AP-C-1); 0.7 to 2.0 T (BTL-899-AP-C-2) Predicate (BTL 799-2L): 0.5 to 1.8 T (BTL 299-6); 0.7 to 2.0 T (BTL 299-7) Conclusion: No significant difference in this parameter range. (Note: Applicator names differ but intensity ranges are equivalent). |
| Pulse Repetition Rate | 1 – 150 Hz | 1 – 150 Hz (Same as predicate) |
| Pulse Duration | For app: BTL-899-AP-C-1: $280 \mu s \pm 20% \mu s$For app: BTL-899-AP-C-2: $190 \mu s \pm 20% \mu s$ | BTL-703-2: $280 \mu s \pm 20% \mu s$ (BTL-899-AP-C-1); $190 \mu s \pm 20% \mu s$ (BTL-899-AP-C-2) Predicate (BTL 799-2L): $280 \mu s \pm 20% \mu s$ (BTL 299-6); $190 \mu s \pm 20% \mu s$ (BTL 299-7) Conclusion: No significant difference in pulse duration. |
| RF Type/Power/Frequency (Bipolar RF part) | Bipolar RF; Total RF Power: 60 W (2x30); RF Frequency: 27.12 MHz | BTL-703-2: Bipolar RF, 60 W (2x30), 27.12 MHz Predicate (BTL 799-2L): N/A (Does not have RF) Reference (BTL-899): Bipolar RF, 60 W (2x30), 27.12 MHz Conclusion: "Not Significantly different" based on comparison to the reference device for the RF aspect. |
| Overheating Protection Sensor | Yes | Yes (Present in BTL-703-2 and reference device BTL-899; N/A for predicate BTL 799-2L which lacks RF). "Not Significantly different." |
| Electrical Safety Standards Compliance | IEC 60601-1 (Basic safety and essential performance) | Complies with IEC 60601-1 |
| EMC Standards Compliance | IEC 60601-1-2 (Electromagnetic disturbances) | Complies with IEC 60601-1-2 |
| Software Standards Compliance | IEC 62304 (Medical device software - Software lifecycle processes) | Complies with IEC 62304 |
| Risk Management Standards Compliance | ISO 14971 (Application of risk management to medical devices) | Complies with ISO 14971 |
| Biocompatibility Standards Compliance | ISO 10993-1 (Evaluation and testing within a risk management process)ISO 10993-5 (Tests for in vitro cytotoxicity)ISO 10993-10 (Tests for irritation and skin sensitization) | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10 |
2. Sample Size Used for the Test Set and Data Provenance
This document describes compliance with non-clinical safety and performance standards, not clinical trials to evaluate efficacy in human subjects (e.g., patient outcomes, image interpretation accuracy). Therefore, "test set" in the context of AI/ML evaluation metrics (like diagnostic accuracy) is not applicable. The "tests" performed are engineering and laboratory tests against recognized standards. The provenance of such testing is internal to the manufacturer or conducted by accredited testing laboratories.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The "ground truth" here is compliance with engineering and safety standards, verified through objective measurements and standard protocols, not expert consensus on medical findings.
4. Adjudication Method
Not applicable. This is not a study requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a powered muscle stimulator, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical device, not an algorithm. Its "standalone performance" refers to its ability to meet the technical specifications described in the table above, which is assessed through non-clinical testing. The document states: "The BTL-703-2 device has been thoroughly evaluated for electrical safety. The device has been found to comply with the following applicable medical device safety standards...".
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation (for 510(k) clearance) is primarily:
- Compliance with recognized electrical safety and EMC standards (e.g., IEC 60601-1, IEC 60601-1-2).
- Compliance with software development lifecycle standards (e.g., IEC 62304).
- Adherence to risk management principles (ISO 14971).
- Biocompatibility of patient-contacting materials (ISO 10993 series).
- Demonstration of technical characteristics (e.g., magnetic field intensity, pulse duration, RF power) comparable to legally marketed predicate/reference devices.
8. Sample Size for the Training Set
Not applicable, as this is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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January 6, 2021
BTL David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752
Re: K200382
Trade/Device Name: BTL-703-2 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: December 10, 2020 Received: December 14, 2020
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 (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 located 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.
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 803) for
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devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200382
Device Name BTL-703-2
Indications for Use (Describe) BTL-703-2 is indicated to be used for:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- · Strengthening, toning and firming of buttocks, thighs and calves.
- · Improvement of muscle tone and firmness, for strengthening muscles in arms.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | □ |
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Image /page/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares, with the letters "BTL" inside the leftmost square. To the right of the squares is the text "BTL Industries" in a dark gray, sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.
510(k) Summary
General Information
| Sponsor: | BTL Industries, Inc.362 Elm StreetMarlborough, MA 01752Tel: +1-866-285-1656Fax: +1-888-499-2502 |
|---|---|
| Fax: +1-888-499-2502 | |
| Applicant: | BTL Industries, Inc.362 Elm StreetMarlborough, MA 01752Tel: +1-866-285-1656Fax: +1-888-499-2502 |
| Contact Person: | David ChmelBTL Industries, Inc.chmel@btlnet.com |
| Summary PreparationDate: | 31 December 2020 |
Device Name
| Trade/Proprietary Name: | BTL-703-2 |
|---|---|
| Primary Classification Name: | Stimulator, Muscle, Powered, Muscle Conditioning |
| Classification Regulation: | 21 CFR 890.5850, Class II |
| Classification Product Code: | NGX |
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Image /page/4/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares with the letters "BTL" inside the leftmost square. To the right of the logo is the text "BTL Industries" in a dark gray sans-serif font. The text is aligned horizontally with the logo.
Legally Marketed Predicate Device
The BTL-703-2 is a state-of-the-art device with accessories combining electromagnetic and high frequency energy, and is substantially equivalent to the following product, which is already cleared for distribution in the USA under the following 510(k) Premarket Notification number:
- 799-2L (K190456) ●
Reference Device BTL-899
The reference device has been added to this section because it is technologically similar to the BTL-703-2 device. Both devices are tracked internally under a common project number, P899. Hence, all test reports and technical documentation refer to this number.
Product Description
The BTL-703-2 is a non-invasive therapeutic device is comprised of a main unit and applicators that deliver electromagnetic and radiofrequency to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators.
The BTL-703-2 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 keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
Indications for Use
BTL-703-2 is indicated to be used for:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, toning and firming of buttocks, thighs and calves.
- Improvement of muscle tone and firmness, for strengthening muscles in arms. ●
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Non-clinical Testing
The BTL-703-2 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 safetyand essential performance |
|---|---|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for basic safetyand essential performance - Collateral standard: Electromagnetic disturbances– Requirements and tests |
| IEC 62304 | Medical device software - Software lifecycle 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 withina 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 skinsensitization |
Technological Characteristics
The BTL-703-2 device has similar indications for use and technological characteristics and principles of operation to its predicate device. The BTL-703-2 device and its predicate are comprised of a system console and applicators. The system console consists of the electromagnetic field and radiofrequency generators, computer, and a touch-screen control panel.
The generated electromagnetic field is intenact with the tissues of the human body in order to achieve muscle stimulation. The radiofrequency is providing a low degree of warming of the applicators and thus enhance the patient's comfort during the treatment.
The mechanism of action and technological similarities and differences between the BTL-703-2 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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Comparison with the Predicate Devices
| 510(k)numberDevice nameCompanyname | K200382BTL-703-2BTL Industries, Inc. | K190456BTL 799-2LBTL Industries, Inc. | Reference DeviceK192224BTL-899BTL Industries, Inc. | Significantdifference |
|---|---|---|---|---|
| ProductCodeandRegulation | Physical Medicine21 CFR 890.5850NGX – Stimulator,Muscle, Powered,Muscle Conditioning | Physical Medicine21 CFR 890.5850NGX - Stimulator,Muscle, Powered,Muscle Conditioning | General & Plastic Surgery21 CFR 878.4400GEI - Electrosurgical,Cutting & Coagulation &Accessories | None |
| Indicationsfor Use | BTL-703-2 is indicatedto be used for:Improvement ofabdominal tone,strengthening ofthe abdominalmuscles,development offirmer abdomen.Strengthening,toning and firmingof buttocks, thighsand calves.Improvement ofmuscle tone andfirmness, forstrengtheningmuscles in arms. | BTL 799-2L isindicated to be usedfor:Improvement ofabdominal tone,strengthening ofthe abdominalmuscles,development offirmer abdomen.Strengthening,toning and firmingof buttocks, thighsand calves.Improvement ofmuscle tone andfirmness, forstrengtheningmuscles in arms. | BTL-899 is indicated tobe used for:Non-invasivelipolysis (breakdownof fat) of theabdomen.Reduction incircumference ofthe abdomenThe BTL-899 is intendedfor use with Skin Type I toSkin Type III. | NotSignificantlydifferent |
| BasicTechnology | Electromagneticstimulationaccompanied bybipolar radiofrequency | Electromagneticstimulation | Electromagneticstimulationaccompanied bybipolar radiofrequency | NotSignificantlydifferentPlease see thediscussion and |
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| conclusionbelow | ||||
|---|---|---|---|---|
| Clinical Use | Prescription use | Prescription use | Prescription use | None |
| ElectricalProtection | Class II, BF | Class II, BF | Class II, BF | None |
| UserInterface | Touch screen | Touch screen | Touch screen | None |
| FirmwareControlled | Yes | Yes | Yes | None |
| Number ofoutputschannels | 2 | 2 | 2 | NotSignificantlydifferent |
| Number ofoutputmodes* | 1 | 1 | 1 | None |
| Number ofMagneticcoilsin theApplicator | 1 | 1 | 1 | None |
| MagneticFieldIntensity (onthe coilsurface) | 0.5 to 1.8 Tfor app:BTL-899-AP-C-1 | 0.5 to 1.8 Tfor app:BTL 299-6 | 0.5 to 1.8 Tfor app:BTL-899-AP-C-1 | None |
| MagneticFieldIntensity (onthe coilsurface) | 0.7 to 2.0 Tfor app:BTL-899-AP-C-2 | 0.7 to 2.0 Tfor app:BTL 299-7 | N/A | None |
| Maximummagnetic | 908 mT | 980 mT | 908 mT | None |
| fieldintensity atapplicatorcentersurface | for app: BTL-899-AP-C-1 | for app:BTL 299-6 | for app: BTL-899-AP-C-1 | None |
| Maximummagneticfieldintensity atapplicatorcentersurface | 1238 mTfor app: BTL-899-AP-C-2 | 1220 mTfor app:BTL 299-7 | 1238 mT | None |
| PulseRepetitionRate -supportedby thedevice | 1 – 150 Hz | 1 – 150 Hz | 1 – 150 Hz | None |
| PulseDuration | $280 \mu s \pm 20% \mu s$for app:BTL-899-AP-C-1 | $280 \mu s \pm 20% \mu s$for app:BTL 299-6 | $280 \mu s \pm 20% \mu s$for app:BTL-899-AP-C-1 | None |
| PulseDuration | $190 \mu s \pm 20% \mu s$for app:BTL-899-AP-C-2 | $190 \mu s \pm 20% \mu s$for app:BTL 299-7 | N/A | None |
| Waveform | Biphasic | Biphasic | Biphasic | None |
| Shape | Sinusoidal | Sinusoidal | Sinusoidal | None |
| RF Type | Bipolar | N/A | Bipolar | NotSignificantlydifferentPlease seediscussion onbasic technologybelow |
| Total RFPower | 60 W (2x30) | N/A | 60 W (2x30) | NotSignificantlydifferentPlease seediscussion onbasic technologybelow |
| RFFrequency | 27.12 Mhz | N/A | 27.12 Mhz | NotSignificantlydifferentPlease seediscussion onbasic technologybelow |
| OverheatingProtectionSensor | Yes | N/A | Yes | NotSignificantlydifferent |
| Selection ofparameters | Yes | Yes | Yes | None |
| Application | Hands-free, applicatorfixed by fixation belt | Hands-free,applicator fixed byfixation belt | Hands-free, applicatorfixed by fixation belt | NotSignificantlydifferent |
| TherapyTime | Up to 30 min | Up to 60 min | Up to 30 min | NotSignificantlydifferent |
| EnergySource | 100 - 240 V AC, 50-60 Hz | 100 - 240 V AC, 50-60 Hz | 100 - 240 V AC, 50-60 Hz | None |
| MaximumOutputVoltage | N/A | N/A | N/A | N/A |
| MaximumOutputCurrent | N/A | N/A | N/A | N/A |
| MaximumCurrentDensity(mA/cm²) | N/A | N/A | N/A | N/A |
| MaximumPhaseCharge,(mC) | N/A | N/A | N/A | N/A |
| MaximumPowerDensity*(W/cm²) | N/A | N/A | N/A | N/A |
| SystemDimensions(W×H×D) | 23 x 39 x 29 in(592 x 985 x 730 mm) | 23 x 55 x 23 in(580x1380x580 mm) | 23 x 39 x 29 in(592 x 985 x 730 mm) | NotSignificantlydifferent |
| SystemWeight | 85 kg | 44 kg | 85 kg | NotSignificantlydifferent |
| AmbientStorageTemperature | 14 °F to 131 °F (-10°Cto +55°C) | 14 °F to 131 °F (-10°C to +55°C) | 14 °F to 131 °F (-10°Cto +55°C) | None |
| RelativeStorageHumidity | 10% to 85% | 10% to 85% | 10% to 85% | None |
| EnvironmentalSpecifications | For indoor use only | For indoor use only | For indoor use only | None |
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Image /page/8/Picture/0 description: The image contains the logo for BTL Industries. The logo consists of three interconnected blue squares with the letters "BTL" inside. To the right of the logo, the words "BTL Industries" are written in a dark gray 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 nested squares with the letters "BTL" inside the innermost square. To the right of the logo is the text "BTL Industries" in a sans-serif font.
Substantial Equivalence
The BTL-703-2 is indicated for improvement of abdominal tone, strengthening of the abdominal muscles and development of firmer abdomen, as well as for strengthening, toning and firming of buttocks, thighs and calves. These indications are the same as the predicate device's indications.
The predicate device BTL-799L utilizes electromagnetic stimulation in order to achieve therapeutic effect. The proposed device BTL-703-2 also utilizes electromagnetic stimulation for its main therapeutic effect; however, the device is also equipped with a bipolar radiofrequency generator. The radiofrequency is warming the applicators' surface to below 40℃ thus enhancing the patient's comfort during the treatment.
The BTL-703-2 electromagnetic technology is identical to FDA cleared predicate device BTL 799-2L. The bipolar radiofrequency technology has also been cleared by FDA in a number of devices, for example BTL-899 (K192224).
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Image /page/11/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares on the left side. To the right of the squares is the text "BTL Industries" in a dark gray, sans-serif font.
Any differences between the predicate device and BTL-703-2 have no significant influence on the safety or effectiveness of the BTL-703-2 device. Therefore, the BTL-703-2 is substantially equivalent to the predicate device.
Conclusion
Based upon the intended use and known technical information provided in this pre-market notification, the BTL-703-2 device has been shown to be substantially equivalent to the currently marketed predicate devices.
§ 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).