(201 days)
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
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.
Based on the provided FDA 510(k) summary for the BTL-899MS device (K240234), here is an analysis of its acceptance criteria and the study proving it meets them:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing detailed clinical study results for a novel device. Therefore, the information regarding acceptance criteria, specific performance metrics, and detailed study methodologies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for novel AI/software devices) is limited or absent. This document primarily outlines compliance with safety and performance standards relevant to a medical device's physical and electrical characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device, the "acceptance criteria" are primarily related to meeting established electrical safety, electromagnetic compatibility, usability, risk management, and biocompatibility standards, and demonstrating substantial equivalence to predicate devices in terms of technological characteristics and intended use. There isn't a table of quantitative performance metrics for disease detection or diagnostic accuracy in this submission because it's a physical therapy device, not an AI diagnostic tool.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance/Compliance |
|---|---|---|
| Electrical Safety | IEC 60601-1: General requirements for basic safety and essential performance | The BTL-899MS device has been "thoroughly evaluated for electrical safety" and "found to comply with the applicable medical device safety standards." |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2: EMC – Requirements and tests | Complies with the standard. |
| Usability | IEC 60601-1-6: General requirements for basic safety and essential performance – Collateral standard: Usability | Complies with the standard. |
| Software Life Cycle Processes | IEC 62304: Medical device software – Software life cycle processes | Complies with the standard. |
| Risk Management | ISO 14971: Medical devices – Application of risk management to medical devices | Complies with the standard. |
| Biocompatibility | ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Complies with the standard. (Specific tests mentioned: ISO 10993-5 for in vitro cytotoxicity and ISO 10993-10 for irritation and skin sensitization). |
| Substantial Equivalence | Comparison to predicate devices (K203488, K200382, K203710) in terms of intended use, technological characteristics, and safety/effectiveness questions. | "The BTL-899MS device has the same intended use and identical technological characteristics and principles of operation to its predicate devices." Differences "do not raise any new types of safety or effectiveness questions." Parameters (magnetic field intensities, pulse durations, magnetic energy densities) are "within the range of values" of primary/third predicates or "equivalent" to the second predicate. Therapy duration differences are addressed by repeated use for comparable energy delivery. Added warming feature is already cleared in a predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states "Clinical Testing: Not applicable" on page 6. This indicates that a clinical study with real patient data (test set) for performance evaluation, as would be expected for an AI/software device, was not conducted or deemed necessary for this 510(k) submission. The evaluation was based on non-clinical testing (bench testing) and comparison to predicate devices, focusing on the device's physical and electrical characteristics and mechanism of action.
Therefore, questions regarding sample size, data provenance (country, retrospective/prospective), experts, and adjudication methods for a test set are not applicable in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical test set for performance evaluation was conducted.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable, as no clinical test set for performance evaluation was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a powered muscle stimulator, not an AI diagnostic device intended to assist human readers (e.g., radiologists interpreting images).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical device, not an algorithm, and its functionality is not standalone in the sense of an AI model's performance.
7. The Type of Ground Truth Used
The "ground truth" for this medical device's acceptance is based on:
- Compliance with established international and national technical standards (e.g., IEC 60601-1, ISO 14971) for safety, EMC, usability, and biocompatibility.
- Demonstrated substantial equivalence to previously cleared predicate devices, meaning its intended use and technological characteristics are similar enough that it does not raise new questions of safety or effectiveness. The "ground truth" for this equivalence often relies on the established safety and efficacy of the predicate devices themselves, backed by their own clearances or long-standing market presence.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 (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
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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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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.362 Elm StreetMarlborough, MA 01752Tel: +1-866-285-1656Fax: +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: | 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 safetyand essential performance |
|---|---|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for basic safetyand essential performance - Collateral standard: Electromagnetic compatibility– Requirements and tests |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basic safetyand 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 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 |
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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)numberDevice name | Not assignedBTL-899MS | K203488emField | K200382BTL-703-2 | K203710MAGNETOLITH |
|---|---|---|---|---|
| Companyname | BTL Industries, Inc. | Zimmer MedizinSysteme GmbH | BTL Industries, Inc. | Storz Medical AG |
| Subject device | Primary predicate | Second predicate | Third predicate | |
| Product CodeandRegulation | Physical Medicine21 CFR 890.5850IPF - Stimulator, Muscle,PoweredNGX - Stimulator, Muscle,Powered, Muscle Conditioning | Physical Medicine21 CFR 890.5850IPF - Stimulator, Muscle, Powered | Physical Medicine21 CFR 890.5850NGX - Stimulator, Muscle,Powered, Muscle Conditioning | Physical Medicine21 CFR 890.5850IPF - Stimulator, Muscle,PoweredNGX - Stimulator, Muscle,Powered, Muscle Conditioning |
| Indications forUse | The BTL-899MS device isindicated to be used for:• Improvement of abdominal tone,strengthening of the abdominalmuscles, development of firmerabdomen.• Strengthening, toning andfirming of buttocks, thighs andcalves.• Improvement of muscle toneand firmness, for strengtheningmuscles in arms.The BTL-899MS device isintended to be used undermedical supervision for adjunctivetherapy for the treatment ofmedical diseases and conditions.The BTL-899MS device isindicated for use in stimulating | The emField is indicated to beused for:• Relaxation of musclespasms;• Prevention or retardationof disuse atrophy;• Increasing local bloodcirculation;• Muscle reeducation;• Immediate postsurgicalstimulation of calfmuscles to preventvenous thrombosis; and• Maintaining or increasingrange of motion. | BTL-703-2 is indicated to be usedfor:Improvement of abdominal tone,strengthening of the abdominalmuscles, development of firmerabdomen.Strengthening, toning and firmingof buttocks, thighs and calves.Improvement of muscle tone andfirmness, for strengtheningmuscles in arms. | Indications for Use:• Relaxation of muscle spasms• Prevention or retardation ofdisuse atrophy• Increasing local bloodcirculation• Muscle re-education• Immediate post-surgicalstimulation of calf muscles toprevent venous thrombosis• Maintaining or increasingrange of motion |
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| neuromuscular tissue for bulkmuscle excitation in the legs orarms for rehabilitative purposes. | ||||
|---|---|---|---|---|
| Indications for Use for MuscleStimulators: | ||||
| • Relaxation of muscle spasms | ||||
| • Prevention or retardation ofdisuse atrophy | ||||
| • Increasing local blood circulation | ||||
| • Muscle re-education | ||||
| • Immediate post-surgicalstimulation of calf muscles toprevent venous thrombosis | ||||
| • Maintaining or increasing rangeof motion | ||||
| ElectricalProtection | 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 ofEnergy | Electromagnetic stimulationaccompanied by bipolarradiofrequency | Magnetic field | Electromagnetic stimulationaccompanied by bipolarradiofrequency | Magnetic field |
| Number ofMagnetic coilsin theApplicators | 1 | 1 | 1 | 1 |
| Number ofApplicators | 2 | 2 | 2 | 1 |
| Number ofoutputchannels | 2 | 1 | 2 | 1 |
| Color TouchScreen | 15.6 in39.6 cm1920 x 1080 px. | 7" | 15.6 in39.6 cm1920 x 1080 px. | 4-line, 7-segment display forviewing and setting therapyparameters |
| Type ofoperation | Continuous | Continuous | Continuous | Continuous |
| PulseRepetitionRate -supported bythe device | 1 — 150 Hz | 1 — 150 Hz | 1 — 150 Hz | 1-10Hz |
| Magnetic FieldIntensity | 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 surface0.08T ±20% at center of coil |
| PulseDuration | 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% |
| PulseAmplitude | 0—100 % | 0–100 % | 0–100 % | multiple adjustable intensitylevels |
| StimulationPulse | Sine, biphasic | Sine, biphasic | Sine, biphasic | Damped sinus, biphasic |
| Magneticenergydensity -Range of thedevice (J/m3) | AP-C-1 - 21.93 - 284.26AP-C-2 - 19.8 - 161.59 | Large applicator: 44.76 - 402.9Small applicator: 17.49 - 279.76 | AP-C-1 - 21.93 - 284.26AP-C-2 - 19.8 - 161.59 | 0.002 - 0.050 |
| RF Type | bipolar | N/A | bipolar | N/A |
| Max. RFPower | 30W per applicator | N/A | 30W per applicator | N/A |
| RF Frequency | 27.12 Mhz | N/A | 27.12 Mhz | N/A |
| TemperatureSensor | Yes | N/A | Yes | N/A |
| Therapy Time | Up to 30 min | Up to 60 min | Up to 30 min | Up to 20 min |
| EnergySource | 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 |
| SystemDimensions(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 |
| SystemWeight | 70 kg | 60 kg | 85 kg | Not known |
| AmbientStorageTemperature | -10°C to +55°C | Not known | -10°C to +55°C | 10 - 20°C |
| RelativeStorageHumidity | 10% to 85% | Not known | 10% to 85% | 5 – 55% |
| EnvironmentalSpecifications | For indoor use only | For indoor use only | For indoor use only | For indoor use only |
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§ 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).