(201 days)
Not Found
No
The summary describes a non-invasive therapeutic device that delivers electromagnetic energy. There is no mention of AI or ML in the device description, intended use, or performance studies. The device operation appears to be based on pre-set parameters controlled via a touch screen, not adaptive algorithms.
Yes
The "Device Description" explicitly states, "The BTL-899MS is a non-invasive therapeutic device." Additionally, its "Intended Use / Indications for Use" lists applications like "Relaxation of muscle spasms," "Prevention or retardation of disuse atrophy," and "Muscle re-education," which are common therapeutic indications.
No
The device is described as a non-invasive therapeutic device used for muscle stimulation and related rehabilitative purposes, not for diagnosing conditions.
No
The device description explicitly states it is comprised of a "main unit and applicators that deliver electromagnetic energy" and is a "non-invasive therapeutic device," indicating it includes hardware components beyond just software.
Based on the provided information, the BTL-899MS device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The intended uses described are all related to stimulating neuromuscular tissue for therapeutic purposes (muscle strengthening, toning, relaxation of spasms, etc.). These are direct treatments applied to the patient's body.
- Device Description: The device delivers electromagnetic energy to the targeted tissue. This is a physical therapy modality, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the BTL-899MS is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
IPF, NGX
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, buttocks, thighs, calves, arms, legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
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).
0
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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).
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
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: | 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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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.
5
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
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 |
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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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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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Comparison with the Predicate Device
| 510(k)
number
Device name | Not assigned
BTL-899MS | K203488
emField | K200382
BTL-703-2 | K203710
MAGNETOLITH |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company
name | BTL Industries, Inc. | Zimmer MedizinSysteme GmbH | BTL Industries, Inc. | Storz Medical AG |
| | Subject device | Primary predicate | Second predicate | Third predicate |
| Product Code
and
Regulation | Physical Medicine
21 CFR 890.5850
IPF - Stimulator, Muscle,
Powered
NGX - Stimulator, Muscle,
Powered, Muscle Conditioning | Physical Medicine
21 CFR 890.5850
IPF - Stimulator, Muscle, Powered | Physical Medicine
21 CFR 890.5850
NGX - Stimulator, Muscle,
Powered, Muscle Conditioning | Physical Medicine
21 CFR 890.5850
IPF - Stimulator, Muscle,
Powered
NGX - Stimulator, Muscle,
Powered, Muscle Conditioning |
| Indications for
Use | The BTL-899MS device 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 | The emField is indicated to be
used for:
• Relaxation of muscle
spasms;
• Prevention or retardation
of disuse atrophy;
• Increasing local blood
circulation;
• Muscle reeducation;
• Immediate postsurgical
stimulation of calf
muscles to prevent
venous thrombosis; and
• Maintaining or increasing
range of motion. | 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. | Indications for Use:
• 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/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
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 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
Energy | Electromagnetic stimulation
accompanied by bipolar
radiofrequency | Magnetic field | Electromagnetic stimulation
accompanied by bipolar
radiofrequency | Magnetic field |
| Number of
Magnetic coils
in the
Applicators | 1 | 1 | 1 | 1 |
| Number of
Applicators | 2 | 2 | 2 | 1 |
| Number of
output
channels | 2 | 1 | 2 | 1 |
| Color Touch
Screen | 15.6 in
39.6 cm
1920 x 1080 px. | 7" | 15.6 in
39.6 cm
1920 x 1080 px. | 4-line, 7-segment display for
viewing and setting therapy
parameters |
| Type of
operation | Continuous | Continuous | Continuous | Continuous |
| Pulse
Repetition
Rate -
supported by
the device | 1 — 150 Hz | 1 — 150 Hz | 1 — 150 Hz | 1-10Hz |
| Magnetic Field
Intensity | AP-C-1 - 0.5 to 1.8 T +/-20%
AP-C-2 - 0.7 to 2.0 T +/-20% | Large applicator: 0.5 - 1.5 T +/-
20%
Small applicator: 0.5 - 2.0 T +/-
20% | AP-C-1 - 0.5 to 1.8 T +/-20%
AP-C-2 - 0.7 to 2.0 T +/-20% | 0.4T ±20% at surface
0.08T ±20% at center of coil |
| Pulse
Duration | AP-C-1 - 280 µs ± 20%
AP-C-2 - 190 µs ± 20% | Large applicator: 400 µs +/- 20%
Small applicator: 250 µs +/- 20% | AP-C-1 - 280 µs ± 20%
AP-C-2 - 190 µs ± 20% | 125µs ± 20% |
| Pulse
Amplitude | 0—100 % | 0–100 % | 0–100 % | multiple adjustable intensity
levels |
| Stimulation
Pulse | Sine, biphasic | Sine, biphasic | Sine, biphasic | Damped sinus, biphasic |
| Magnetic
energy
density -
Range of the
device (J/m3) | AP-C-1 - 21.93 - 284.26
AP-C-2 - 19.8 - 161.59 | Large applicator: 44.76 - 402.9
Small applicator: 17.49 - 279.76 | AP-C-1 - 21.93 - 284.26
AP-C-2 - 19.8 - 161.59 | 0.002 - 0.050 |
| RF Type | bipolar | N/A | bipolar | N/A |
| Max. RF
Power | 30W per applicator | N/A | 30W per applicator | N/A |
| RF Frequency | 27.12 Mhz | N/A | 27.12 Mhz | N/A |
| Temperature
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
Source | 100 – 240 V AC, 50-60 Hz | 100 – 240 V AC, 50-60 Hz,
max. 12,5 A | 100 – 240 V AC, 50–60 Hz | 100 - 240 V AC, 50/60 Hz |
| System
Dimensions
(W×H×D) | 23 × 39 × 29 in
(592 x 985 x 730 mm) | 542 x 501 x 993 mm | 23 × 39 × 29 in
(592 x 985 x 730 mm) | 454 x 187 x 460 mm |
| System
Weight | 70 kg | 60 kg | 85 kg | Not known |
| Ambient
Storage
Temperature | -10°C to +55°C | Not known | -10°C to +55°C | 10 - 20°C |
| Relative
Storage
Humidity | 10% to 85% | Not known | 10% to 85% | 5 – 55% |
| Environmental
Specifications | For indoor use only | For indoor use only | For indoor use only | For indoor use only |
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11
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