BTL-899MS

K240234 · BTL Industries, Inc. · IPF · Aug 17, 2024 · Physical Medicine

Device Facts

• Record ID: K240234
• Device Name: BTL-899MS
• Applicant: BTL Industries, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Aug 17, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BTL-899MS is indicated to be used for: · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. - · Strenathening, toning and firming of buttocks, thighs and calves. - · Improvement of muscle tone and firmness, for strengthening muscles in arms. The BTL-899MS device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. The BTL-899MS 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

Device Story

BTL-899MS is a non-invasive therapeutic device delivering electromagnetic energy and bipolar radiofrequency (RF) to targeted tissue. System comprises a main console with a color touch-screen and two applicators for simultaneous, hands-free treatment. Device operates by inducing magnetic stimulation of underlying tissue, accompanied by sub-therapeutic warming to increase patient comfort. Physician or trained operator sets therapeutic parameters (pulse duration, magnetic field intensity, frequency) via touch-screen; device provides step-by-step guidance. Temperature sensors monitor and regulate the warming modality. Output affects neuromuscular tissue, promoting bulk muscle excitation, increased local blood circulation, and muscle relaxation. Used in clinical settings under medical supervision for adjunctive therapy. Benefits include improved muscle tone, prevention of atrophy, and rehabilitation of muscle function.

Clinical Evidence

No clinical data. Bench testing only. Device evaluated for electrical safety and performance per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304, ISO 14971, and ISO 10993 series (cytotoxicity, irritation, sensitization).

Technological Characteristics

System console with generators, computer, and 15.6-inch color touch-screen. Delivers electromagnetic stimulation (1-150 Hz) and 27.12 MHz bipolar RF (30W/applicator). Two output channels; two applicators. Magnetic field intensity 0.5-2.0 T. Pulse duration 190-280 µs. Includes temperature sensors for RF monitoring. Class II, BF electrical protection. Indoor use. Software life cycle per IEC 62304.

Indications for Use

Indicated for patients requiring muscle strengthening, toning, or firming (abdomen, buttocks, thighs, calves, arms), relaxation of muscle spasms, prevention/retardation of disuse atrophy, increased local blood circulation, muscle re-education, post-surgical calf stimulation to prevent venous thrombosis, and maintenance/increase of range of motion.

Regulatory Classification

Identification

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

Predicate Devices

• emField (K203488)
• BTL-703-2 (K200382)
• MAGNETOLITH (K203710)

Submission Summary (Full Text)

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August 17, 2024

BTL Industries, Inc David Chmel CEO North America 362 Elm Street Marlborough, Massachusetts 01752

Re: K240234

Trade/Device Name: Btl-899ms Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, NGX Dated: July 9, 2024 Received: July 9, 2024

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" (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).

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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 QS 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Jitendra V. Virani -S

CDR Jitendra Virani Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

#### K240234

Device Name

BTL-899MS

Indications for Use (Describe)

BTL-899MS is indicated to be used for:

· Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.

- · Strenathening, toning and firming of buttocks, thighs and calves.
- · Improvement of muscle tone and firmness, for strengthening muscles in arms.

The BTL-899MS device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The BTL-899MS 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)

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 gray sans-serif font.

# 510(k) Summary

#### General Information

| Sponsor: | BTL Industries, Inc.<br>362 Elm Street<br>Marlborough, MA 01752<br>Tel: [phone]<br>Fax: [phone] |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.<br>362 Elm Street<br>Marlborough, MA 01752<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person: | David Chmel<br>BTL Industries, Inc.<br>[e-mail] |
| Summary Preparation<br>Date: | 14 August 2024 |

#### Device Name

| Trade/Proprietary Name: | BTL-899MS |
|-------------------------|---------------------------|
| Regulation Number: | 21 CFR 890.5850 |
| Regulation Name: | Powered Muscle Stimulator |
| Regulatory Class: | Class II |
| Product Code: | IPF, NGX |

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Image /page/4/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.

#### Legally Marketed Predicate Device

The BTL-899MS is a state-of-the-art device with accessories using the electromagnetic energy for therapeutic purposes and is substantially equivalent to the current products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers:

Primary predicate:

Device name: emField Original 510(k) Sponsor: Zimmer MedizinSysteme GmbH 510(k) Number: K203488

Second predicate:

Device name: BTL-703-2 Original 510(k) Sponsor: BTL Industries, Inc 510(k) Number: K200382

Third predicate:

Device name: MAGNETOLITH Original 510(k) Sponsor: Storz Medical AG 510(k) Number: K203710

#### Product Description

The BTL-899MS is a non-invasive therapeutic device. The device is comprised of a main unit and applicators that deliver electromagnetic energy to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators.

The application of electromagnetic energy to the patient's feeling of magnetic stimulation of underlying tissue accompanied by a pleasant feeling of warming 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-899MS is equipped with a large color touch-screen that 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 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.

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Image /page/5/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" in white inside the innermost square. To the right of the square logo is the text "BTL Industries" in a gray, sans-serif font.

#### Indications for Use

BTL-899MS 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-899MS device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The BTL-899MS 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

#### Non-clinical Testing (Performance, Bench Testing)

The BTL-899MS 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<br>and essential performance |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for basic safety<br>and essential performance - Collateral standard: Electromagnetic compatibility<br>– Requirements and tests |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basic safety<br>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<br>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<br>sensitization |

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Image /page/6/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" in white inside the innermost square. To the right of the square logo is the text "BTL Industries" in a gray, sans-serif font. The logo is simple and modern, and the colors are clean and professional.

#### Clinical Testing

Not applicable

#### Technological Characteristics

The BTL-899MS device has the same intended use and identical technological characteristics and principles of operation to its predicate devices. The BTL-899MS device and its predicates are comprised of a system console and applicator(s). 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-899MS device and the predicate devices are described below in the comparison table. The differences do not raise any new types of safety or effectiveness questions.

#### Substantial Equivalence

The subject device is capable of providing therapy in two output channels. The device is able to start the therapy and carry out the same treatment in both channels at the same time, with parameters (pulse duration, magnetic field intensity, and frequency) adjustable for each channel separately within the ranges described in the table below. This allows each channel to function output. The device is still intended to be used on only one patient at a time, and the two channels are not intended to be used on the same muscle or on agonist and antagonist muscles. The ability to adjust the parameters and output power (intensity) separately for each channel allows the output power of each applicator to be tailored to the needs of the patient and the area being treated. This approach allows optimization of the treatment and ensures that each treated area receives the necessary stimulation. Therefore, this functionality does not raise any unacceptable risks or any unacceptable safety or effectiveness questions compared to the predicate device.

The magnetic field intensities, pulse durations, and magnetic energy densities of the subject device are within the range of values of the primary predicate (K203488) and third predicate (K203710) devices, which are both cleared for the same indications as the subject device under product code IPF. Therefore, these differences do not raise any unacceptable risks or any unacceptable safety or effectiveness questions compared to the predicate devices. The magnetic field intensities, pulse durations, and magnetic energy densities of the subject device are equivalent to the range of values of the second predicate device (K200382) that is cleared for the same indications as the subject device under product code NGX.

The maximum energy density delivered by the primary predicate device could be greater than the maximum energy density delivered to the tissue by the subject device, but energy densities delivered by the applicators of the subject device are within the set range of energy densities of the primary and third predicate devices. If we follow the instructions for the use of these devices the device settings and maximum therapy intensity should be adjusted based on patient feedback and after careful consideration of the patient's adequate needs by the physician. As for the lower total value of energy

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Image /page/7/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares on the left side of the image. To the right of the squares is the text "BTL Industries" in a dark gray sans-serif font.

delivered to the tissue by the subject device compared to primary predicate, this total value of energy delivered, if deemed appropriate by the physician, can be adjusted to the primary predicate device by extending the time of application of the therapy. Therefore, these differences do not raise any unacceptable risks or any unacceptable safety or effectiveness questions compared to the predicate devices.

The subject device has a standard adjustable therapy duration of up to 30 minutes, which differs from the primary predicate device, which allows therapy to be set for up to 60 minutes and from the third predicate device, which allows therapy to be set for up to 20 minutes. However, the device has comparable output parameters to the primary predicate device in terms of maximum frequency, maximum magnetic field intensity and pulse duration. The subject device also fits within the set range of these parameters by its predicate devices. 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 comparable as for the predicate device. Therefore, this difference does not raise any unacceptable risks or unacceptable questions in relation to safety or efficacy.

BTL-899MS incorporates application of the warming on sub-therapeutic level at the patient application site to increase patient convenience during therapy. Based on this additional energy presence, there is a temperature sensor to monitor and regulate this additional modality. The application of additional warming as a supportive modality to increase comfort and provide a more convenient therapy has been used and already cleared for the second predicate device. Therefore the application of additional energy does not raise any unacceptable risks or questions related to safety or effectiveness.

The differences related to weight & dimensions, color touch screen size and storage conditions parameters do not have any significant effect on the efficiency or safety of the device.

The BTL-899MS device has the same intended use as its predicate devices. The technological characteristics of the predicate devices are similar to the BTL-899MS device. Any differences between the predicate devices and BTL-899MS have no significant influence on safety and effectiveness of the BTL-899MS device. Therefore, the BTL-899MS is substantially equivalent to the predicate devices.

## Conclusion

Based upon the comparison of the intended use and the technological characteristics, the BTL-899MS device has been shown to be substantially equivalent to the currently marketed predicate devices.

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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" in white 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)<br>number<br>Device name | Not assigned<br>BTL-899MS | K203488<br>emField | K200382<br>BTL-703-2 | K203710<br>MAGNETOLITH |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company<br>name | BTL Industries, Inc. | Zimmer MedizinSysteme GmbH | BTL Industries, Inc. | Storz Medical AG |
| | Subject device | Primary predicate | Second predicate | Third predicate |
| Product Code<br>and<br>Regulation | Physical Medicine<br>21 CFR 890.5850<br>IPF - Stimulator, Muscle,<br>Powered<br>NGX - Stimulator, Muscle,<br>Powered, Muscle Conditioning | Physical Medicine<br>21 CFR 890.5850<br>IPF - Stimulator, Muscle, Powered | Physical Medicine<br>21 CFR 890.5850<br>NGX - Stimulator, Muscle,<br>Powered, Muscle Conditioning | Physical Medicine<br>21 CFR 890.5850<br>IPF - Stimulator, Muscle,<br>Powered<br>NGX - Stimulator, Muscle,<br>Powered, Muscle Conditioning |
| Indications for<br>Use | The BTL-899MS device is<br>indicated to be used for:<br>• Improvement of abdominal tone,<br>strengthening of the abdominal<br>muscles, development of firmer<br>abdomen.<br>• Strengthening, toning and<br>firming of buttocks, thighs and<br>calves.<br>• Improvement of muscle tone<br>and firmness, for strengthening<br>muscles in arms.<br>The BTL-899MS device is<br>intended to be used under<br>medical supervision for adjunctive<br>therapy for the treatment of<br>medical diseases and conditions.<br>The BTL-899MS device is<br>indicated for use in stimulating | The emField is indicated to be<br>used for:<br>• Relaxation of muscle<br>spasms;<br>• Prevention or retardation<br>of disuse atrophy;<br>• Increasing local blood<br>circulation;<br>• Muscle reeducation;<br>• Immediate postsurgical<br>stimulation of calf<br>muscles to prevent<br>venous thrombosis; and<br>• Maintaining or increasing<br>range of motion. | BTL-703-2 is indicated to be used<br>for:<br>Improvement of abdominal tone,<br>strengthening of the abdominal<br>muscles, development of firmer<br>abdomen.<br>Strengthening, toning and firming<br>of buttocks, thighs and calves.<br>Improvement of muscle tone and<br>firmness, for strengthening<br>muscles in arms. | Indications for Use:<br>• Relaxation of muscle spasms<br>• Prevention or retardation of<br>disuse atrophy<br>• Increasing local blood<br>circulation<br>• Muscle re-education<br>• Immediate post-surgical<br>stimulation of calf muscles to<br>prevent venous thrombosis<br>• Maintaining or increasing<br>range of motion |

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Image /page/9/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interlocking squares with the letters "BTL" inside the leftmost square. The words "BTL Industries" are written to the right of the squares in a sans-serif font. The color of the logo and text is a dark gray-blue.

| | neuromuscular tissue for bulk<br>muscle excitation in the legs or<br>arms for rehabilitative purposes. | | | |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|
| | Indications for Use for Muscle<br>Stimulators: | | | |
| | • Relaxation of muscle spasms | | | |
| | • Prevention or retardation of<br>disuse atrophy | | | |
| | • Increasing local blood circulation | | | |
| | • Muscle re-education | | | |
| | • Immediate post-surgical<br>stimulation of calf muscles to<br>prevent venous thrombosis | | | |
| | • Maintaining or increasing range<br>of motion | | | |
| Electrical<br>Protection | Class II, BF | Class I, BF | Class II, BF | Class I, B |
| Clinical Use | Prescription use | Prescription use | Prescription use | Prescription use |
| Interface | Touch screen | Touch screen | Touch screen | Touch screen |
| Type of<br>Energy | Electromagnetic stimulation<br>accompanied by bipolar<br>radiofrequency | Magnetic field | Electromagnetic stimulation<br>accompanied by bipolar<br>radiofrequency | Magnetic field |
| Number of<br>Magnetic coils<br>in the<br>Applicators | 1 | 1 | 1 | 1 |
| Number of<br>Applicators | 2 | 2 | 2 | 1 |
| Number of<br>output<br>channels | 2 | 1 | 2 | 1 |
| Color Touch<br>Screen | 15.6 in<br>39.6 cm<br>1920 x 1080 px. | 7" | 15.6 in<br>39.6 cm<br>1920 x 1080 px. | 4-line, 7-segment display for<br>viewing and setting therapy<br>parameters |
| Type of<br>operation | Continuous | Continuous | Continuous | Continuous |
| Pulse<br>Repetition<br>Rate -<br>supported by<br>the device | 1 — 150 Hz | 1 — 150 Hz | 1 — 150 Hz | 1-10Hz |
| Magnetic Field<br>Intensity | AP-C-1 - 0.5 to 1.8 T +/-20%<br>AP-C-2 - 0.7 to 2.0 T +/-20% | Large applicator: 0.5 - 1.5 T +/-<br>20%<br>Small applicator: 0.5 - 2.0 T +/-<br>20% | AP-C-1 - 0.5 to 1.8 T +/-20%<br>AP-C-2 - 0.7 to 2.0 T +/-20% | 0.4T ±20% at surface<br>0.08T ±20% at center of coil |
| Pulse<br>Duration | AP-C-1 - 280 µs ± 20%<br>AP-C-2 - 190 µs ± 20% | Large applicator: 400 µs +/- 20%<br>Small applicator: 250 µs +/- 20% | AP-C-1 - 280 µs ± 20%<br>AP-C-2 - 190 µs ± 20% | 125µs ± 20% |
| Pulse<br>Amplitude | 0—100 % | 0–100 % | 0–100 % | multiple adjustable intensity<br>levels |
| Stimulation<br>Pulse | Sine, biphasic | Sine, biphasic | Sine, biphasic | Damped sinus, biphasic |
| Magnetic<br>energy<br>density -<br>Range of the<br>device (J/m3) | AP-C-1 - 21.93 - 284.26<br>AP-C-2 - 19.8 - 161.59 | Large applicator: 44.76 - 402.9<br>Small applicator: 17.49 - 279.76 | AP-C-1 - 21.93 - 284.26<br>AP-C-2 - 19.8 - 161.59 | 0.002 - 0.050 |
| RF Type | bipolar | N/A | bipolar | N/A |
| Max. RF<br>Power | 30W per applicator | N/A | 30W per applicator | N/A |
| RF Frequency | 27.12 Mhz | N/A | 27.12 Mhz | N/A |
| Temperature<br>Sensor | Yes | N/A | Yes | N/A |
| Therapy Time | Up to 30 min | Up to 60 min | Up to 30 min | Up to 20 min |
| Energy<br>Source | 100 – 240 V AC, 50-60 Hz | 100 – 240 V AC, 50-60 Hz,<br>max. 12,5 A | 100 – 240 V AC, 50–60 Hz | 100 - 240 V AC, 50/60 Hz |
| System<br>Dimensions<br>(W×H×D) | 23 × 39 × 29 in<br>(592 x 985 x 730 mm) | 542 x 501 x 993 mm | 23 × 39 × 29 in<br>(592 x 985 x 730 mm) | 454 x 187 x 460 mm |
| System<br>Weight | 70 kg | 60 kg | 85 kg | Not known |
| Ambient<br>Storage<br>Temperature | -10°C to +55°C | Not known | -10°C to +55°C | 10 - 20°C |
| Relative<br>Storage<br>Humidity | 10% to 85% | Not known | 10% to 85% | 5 – 55% |
| Environmental<br>Specifications | For indoor use only | For indoor use only | For indoor use only | For indoor use only |

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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 on the left side of the image. The text "BTL Industries" is on the right side of the image.

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Image /page/11/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three nested squares, with the letters "BTL" inside the innermost square. The text "BTL Industries" is in a sans-serif font and is a dark gray color.