(597 days)
BEMER therapy systems (BEMER Classic Set, BEMER Pro-Set) are indicated for:
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance
BEMER therapy systems are a family of noninvasive physical medicine devices that can be used as a supportive therapy to increase local blood circulation. BEMER therapy is offered in two system options-Classic and Professional. Both systems consist of a B.BOX console, a set of BEMER signal applicators, power pack, B.SCAN indicator and accessories for attachment. The B.PAD and B.SPOT applicators have been cleared for use in this submission.
BEMER systems improve local blood distribution via electromagnetic stimulatory principles. The resulting increase in local blood distribution can broadly benefit patients. The indications for use allow the application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance.
Acceptance Criteria and Device Performance:
The provided document is a 510(k) summary for the BEMER Classic Set and BEMER Pro-Set. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining explicit acceptance criteria with specific performance metrics for the BEMER device itself.
However, the "Performance Testing" section states that "BEMER therapy systems are compliant with the following standards and have outputs that are within the same range as the predicate devices". This implies that the 'acceptance criteria' for the BEMER device's performance are that it meets these standards and operates within a comparable range to the predicate.
The "Technical and Performance Comparison" table (Table 12.1) details the comparison between the BEMER Therapy Systems (Subject Device) and the predicate device (Revitive IX, K143207) and a reference device (Neotonus MS-101 Magnetic Muscle Stimulator System, K973929).
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the document, direct acceptance criteria with specific numerical thresholds for increased blood circulation or improved muscle performance are not provided. Instead, the acceptance is based on demonstrating substantial equivalence by meeting regulatory standards and having comparable technical characteristics and functionality to the predicate device.
| Feature / Criteria (Implied) | Predicate Device (Revitive IX, K143207) Performance | Subject Device (BEMER Therapy Systems) Performance | Comparison Comments (from document) |
|---|---|---|---|
| Indications for Use (Key Acceptance) | - Temporarily increase local blood circulation in healthy leg muscles. - Stimulate healthy muscles to improve/facilitate muscle performance. | - Temporarily increase local blood circulation in healthy leg muscles. - Stimulate healthy muscles to improve/facilitate muscle performance. | Same/Substantially Equivalent |
| Mode of Action | Non-invasive tissue stimulation via skin electrodes. | Non-invasive tissue stimulation via magnetic field induction. | "Effectiveness: As the mode of action differs from direct induction (predicate device) to indirect induction (subject device), safety and effectiveness must be proven via a comparative series of measurements" |
| Waveform | Pulsed symmetrical, constant amplitude during treatment. | Pulsed asymmetric, constant amplitude during treatment. | Minor difference, no impact on safety and effectiveness. |
| Shape | Rectangular, bipolar. | Sinusoidal, monopolar. | Minor difference, no impact on safety and effectiveness. |
| Pulse repetition rate | Foot: 20-53Hz; Body: 35-46Hz. | All accessories: 10-30Hz. | Minor difference, no impact on safety and effectiveness. |
| Single pulse duration | Foot: 0.4 - 7.5µS; Body: 1.4 - 33.6µS. | All accessories: 10 - 33µS. | Minor difference, no impact on safety and effectiveness. |
| Maximum Power density applied | Foot: 0.023 mA/cm2; Body: 0.082 mA/cm2. | All accessories: 35 - 100μT. | Minor difference, no impact on safety and effectiveness. |
| Maximum output voltage | @500Ω: 20-32V; @2kΩ: 95-118V; @10kΩ: 138-169V. | N/A (Does not directly apply voltage). | "Safety: The subject device does not directly apply voltage to the human body. Therefore, no new hazards were identified." |
| Maximum Output Current (directly applied) | @500Ω: 40-64mA; @2kΩ: 48-59mA; @10kΩ: 14-17mA. | All accessories: <5mA (acc. to IEC 60601-1). | "Effectiveness: As the mode of action differs... safety and effectiveness must be proven via a comparative series of measurements" |
| Compliance with Voluntary Standards (e.g., IEC60601-1) | EN 60601-1, EN 60601-1-2, EN60601-1-11. | IEC60601-1, IEC 60601-1-2, EN 60601-1-6, EN 62366, EN 60601-1-11. | Both devices compliant with relevant safety and EMC standards. |
| Usability | Not explicitly detailed for predicate. | Usability study conducted to demonstrate safe and effective operation by lay and professional users, suitable for OTC use. | BEMER systems, as labeled, are safe and effective in use by lay and professional users and suitable for OTC use. |
| Overall Safety and Effectiveness (Conclusion of SE) | Predicate is legally marketed as safe and effective. | "The Bemer Therapy System is as safe and effective as its predicate device." "The differences... raise no new safety or effectiveness issues." "Clinical performance data demonstrate that BEMER therapy Systems are as safe as the predicate device and it is suitable for Over-The-Counter (OTC)." | The BEMER Therapy Systems are substantially equivalent to the predicate. |
Study Information:
The document (510(k) summary) describes the basis for a Substantial Equivalence (SE) determination to a predicate device, rather than a de novo clinical trial with specific performance endpoints. The primary "study" proving the device meets the (implied) acceptance criteria is the comparative analysis to the predicate device and compliance with recognized standards.
Key points from the document regarding studies:
2. Sample size used for the test set and data provenance:
- The document mentions "clinical performance data" to support its safety and suitability for OTC use but does not provide details on the sample size of any specific clinical test set.
- It states that "safety and effectiveness must be proven via a comparative series of measurements" due to the different mode of action, but the details of these measurements (sample size, data provenance) are not included in this summary.
- The provenance of data for any comparative measurements or clinical studies is not explicitly stated (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the 510(k) summary. The document does not describe a process where experts established ground truth for a test set in the context of typical diagnostic device evaluation (e.g., imaging studies). The evaluation appears to be based on engineering principles, compliance with standards, and comparison of technical specifications and intended use.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- As there's no mention of a traditional "test set" and expert ground truth establishment for diagnostic performance, no adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was described. The BEMER device is a physical medicine device (a powered muscle stimulator), not an AI-powered diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This concept is not applicable to this type of medical device (physical stimulator).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's claims (temporarily increase local blood circulation, stimulate healthy muscles) is primarily established through scientific literature on electromagnetic stimulation, engineering principles, and comparison to the predicate device's established efficacy and safety.
- The document implies that "clinical performance data" was used, and the "Usability study" serves as "performance data" for safe and effective use by lay and professional users based on their knowledge and instructions. The ground truth for usability would be the users' ability to correctly and safely operate the device as observed during the usability study.
8. The sample size for the training set:
- There's no mention of a "training set" as this is not an AI/machine learning device. The design and development would follow traditional medical device engineering processes.
9. How the ground truth for the training set was established:
- This concept is not applicable as there is no "training set."
Summary of the "study" proving acceptance:
The primary "proof" relies on demonstrating that the BEMER Therapy Systems are substantially equivalent to legally marketed predicate devices. This involves:
- Comparison of Indications for Use: Showing identical intended uses for the BEMER device and the predicate.
- Comparison of Technological Characteristics: Analyzing features like mode of action, waveform, pulse repetition rate, output parameters, and identifying any differences. For differences, the document provides comments on whether these differences impact safety and effectiveness (e.g., "Minor difference, no impact on safety and effectiveness").
- Compliance with Recognized Standards: Declaration of conformity to numerous IEC standards (e.g., IEC 60601-1 for safety, IEC 60601-1-2 for EMC) and ISO standards (e.g., ISO 10993-1 for biocompatibility). These standards inherently contain their own acceptance criteria for safety and performance under various conditions.
- Usability Study: A usability study was explicitly conducted and followed FDA's human factors guidance to ensure that intended users can operate the device safely and effectively. The results confirmed its suitability for Over-The-Counter (OTC) use.
- Clinical Performance Data (mentioned but not detailed): The document generally states that "Clinical performance data demonstrate that BEMER therapy Systems are as safe as the predicate device and it is suitable for Over-The-Counter (OTC)." However, the specifics of these clinical studies (methodology, sample size, endpoints, results) are not elaborated in this summary. It's possible these details were provided in other parts of the 510(k) submission, but not in this public summary.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2017
Sven Bieler, PhD Regulatory Affairs BEMER Int. AG Austrasse 15 Triesen, 9495 Liechtenstein
Re: K151834
Trade/Device Name: BEMER Classic Set, BEMER Pro-Set Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: January 23, 2017 Received: January 23, 2017
Dear Dr. Bieler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
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as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151834
Device Name BEMER Classic Set and BEMER Pro-Set
Indications for Use (Describe)
-
To temporarily increase local blood circulation in healthy leg muscles
-
To stimulate healthy muscles in order to improve and facilitate muscle performance
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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6. 510(K) SUMMARY
The following information is provided as required by 21 CFR 807.92 for BEMER International, AG's BEMER Therapy Systems 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.
- Sponsor: BEMER International, AG Austrasse 15 LIE-9495 Triesen, Liechtenstein Phone: +423-399-3999 Fax: +423-399-3998 Registration Number: 30039102830
- Contact: BEMER International AG Sven Bieler, Fred Harms Austrasse 15 LIE-9495 Triesen, Liechtenstein Phone: +423 399 3999 Fax: +423 399 3998
| Date of Submission: | February 22, 2017 |
|---|---|
| Proprietary Name(s): | BEMER Classic Set and BEMER Pro-Set |
| Common Name: | Powered Muscle Stimulator, Powered Muscle Stimulator forMuscle Conditioning |
| Regulatory Class: | II |
| Regulation: | 21 CFR 890.5850 |
| Panel: | Physical Medicine |
| Product Codes: | NGX |
| Predicate Device: | K143207, Revitive IX (OTC) |
| Reference Device: | K973929, Neotonus Model 1000 Muscle Stimulator System |
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Device Description:
BEMER therapy systems are a family of noninvasive physical medicine devices that can be used as a supportive therapy to increase local blood circulation. BEMER therapy is offered in two system options-Classic and Professional. Both systems consist of a B.BOX console, a set of BEMER signal applicators, power pack, B.SCAN indicator and accessories for attachment. The B.PAD and B.SPOT applicators have been cleared for use in this submission.
BEMER systems improve local blood distribution via electromagnetic stimulatory principles. The resulting increase in local blood distribution can broadly benefit patients. The indications for use allow the application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance.
BEMER therapy systems are substantially equivalent to other legally marketed over-thecounter devices within physical medicine classifications NGX (Powered Muscle stimulator). Generally, these are non-invasive and reusable muscle conditioning devices that stimulate muscle contractile properties, force output and/or fatigue resistance. These devices also improve local blood circulation in muscle tissue. These devices create electric stimulation either via direct application of electric current or via induction of electrical stimulation within the tissue by application of magnetic flux. All are used for therapy regimes lasting days to weeks with one or more individual treatments per day lasting generally less than an hour. All are designed for patient-managed self-use in a home setting.
BEMER Therapy Systems utilize induction of microcurrents to tissue. Like the reference device, this non-invasive electromagnetic stimulation improves muscle activity induced by electromagnetic stimulation.
Intended Use:
BEMER therapy systems (BEMER Classic Set, BEMER Pro-Set) are indicated for:
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance
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Performance Testing:
BEMER therapy systems are compliant with the following standards and have outputs that are within the same range as the predicate devices:
| STANDARD | DESCRIPTION |
|---|---|
| 510(k) Declaration of Conformity Standards | |
| IEC/EN 60601-1:2007 | Medical Electrical Equipment, Part 1,General Requirements for Safety |
| IEC 60601-1-2:2014 | Medical Electrical Equipment, Part 1-2, General Requirement forSafety. Electromagnetic Compatibility |
| IEC/EN 60601-1-4:2001 | Medical Electrical Equipment, Part 1-4, Collateral Standard:Programmable electrical medical systems. |
| IEC/EN 60601-1-6: 3rd | Medical Electrical Equipment, Part 1-6, Usability |
| IEC/EN 60601-1-11: 2010 | Medical Electrical Equipment, Part 1-11,General requirements for basic safety and essential performance–Collateral Standard: Requirements for medical electricalequipment and medical electrical systems used in the homehealthcare environment |
| IEC/EN 62366 | Medical devices - Application of usability engineering to medicaldevices |
| EN ISO 10993-1:2009 | Biological Evaluation of Medical Devices Part 1: Evaluation andTesting(Overall plan and requirements established internally, specifictests conducted by 3rd party, see Section 16) |
| General Compliance Standards | |
| EN ISO 13485:2012 | Medical Devices, Quality Management Systems, Requirementsfor Regulatory Purposes |
| EN ISO 14971 | Application of risk management to medical products |
| IEC/EN 62304 | Software life cycle processes |
Technical and Performance Comparison:
The subject and predicate devices are all non-invasive, reusable, and used as therapies for wide-ranging conditions resulting in pain, atrophy, and reduced circulation (loss of vascular and muscle tone). All employ the same general principles of tissue and cellular stimulation; some stimulate via direct electrical stimulation, while others induce electrical stimulation within the tissue by the application of magnetic flux.
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| BEMER TherapySystems | Revitive IX(K143207) | Neotonus MS-101Magnetic MuscleStim. System(K973929)Reference Device | Comments | |
|---|---|---|---|---|
| SUBJECT DEVICE | Predicate Device | |||
| ClassificationCode(s) | Primary: PoweredMuscle StimulatorNGX 890.5850 | Primary: PoweredMuscle StimulatorNGX 890.5850 | Powered MuscleStimulatorIPF 890.5850 | |
| Secondary:TranscutaneousNerve StimulatorNUH 882.5890 | ||||
| Indications forUse | [Pending] TheBEMER therapy isindicated:To temporarilyincrease localblood circulation inhealthy legmuscles.- To stimulatehealthymuscles inorder toimprove andfacilitatemuscleperformance. | To temporarilyincrease localblood circulation inhealthy legmuscles.- To stimulatehealthymuscles inorder toimprove andfacilitatemuscleperformance.- For temporaryrelief of painassociatedwith sore andachingmuscles in theshoulder,waist, back,upperextremities(arms) andlowerextremities(legs) due tostrain fromexercise ornormalhouseholdduties. | The Neotonus MS-101 MagneticMuscle StimulatorSystem is intendedto be used undermedicalsupervision foradjunctive therapyfor the treatment ofmedical diseasesand conditions.The Neotonus MS-101 is indicated foruse in stimulatingneuromusculartissues for bulkmuscle excitationin the legs or armsfor rehabilitativepurposes.Indications for Usefor MuscleStimulators:Relaxation ofmuscle spasms,prevention orretardation ofdisuse atrophy,increasing localblood circulation,muscle re-education,immediate post-surgical stimulationof calf muscles toprevent venousthrombosis,maintaining or | |
| BEMER | Revitive IX(K143207) | Neotonus(K973929) | ||
| PRIMARY MODE OF ACTION | Non-invasive tissue stimulation via magnetic field induction | Non-invasive tissue stimulation via skin electrodes | Non-invasive tissue stimulation via magnetic field induction | |
| Waveform | Pulsed asymmetric, constant amplitude during treatment | Pulsed symmetrical, constant amplitude during treatment | Unknown | Minor difference, no impact on safety and effectiveness. |
| Shape | Sinusoidal, monopolar | Rectangular, bipolar | Unknown | Minor difference, no impact on safety and effectiveness |
| Pulse repetition rate | All accessories: 10-30Hz | Foot: 20-53HzBody: 35-46Hz | 1-55Hz | Minor difference, no impact on safety and effectiveness |
| Single pulse duration | All accessories: 10 - 33μS | Foot:0.4 - 7.5µSBody: 1.4 - 33.6µS | 18-1000µS | Minor difference, no impact on safety and effectiveness |
| Maximum Power density applied:: | All accessories: 35 - 100μT | Foot:0.023 mA/cm2Body:0.082 mA/cm2 | 1-100% | Minor difference, no impact on safety and effectiveness |
| Maximum output voltage | N/A | @500Ω: 20-32V@2kΩ: 95-118V@10kΩ: 138-169V | Unknown | Safety: The subject device does not directly apply voltage to the human body. Therefore, no new hazards were identified. |
| Maximum Output Current | Current directly applied to the patient's bodyAll accessories:<5mA (acc. to IEC 60601-1) | Current directly applied to the patient's body:@500Ω: 40-64mA@2kΩ: 48-59mA@10kΩ: 14-17mA | Unknown | Effectiveness: As the mode of action differs from direct induction (predicate device) to indirect induction (subject device), safety and effectiveness must be proven via a comparative series of measurements |
| Treatment mode, Treatment Mode, Treatment Time | ||||
| Basic PlanTreatment | Local applicator(B:PAD, B.SPOT,max. 2 applicatorsconnected to thedevice)Local treatment onskeletal muscles –to be used inseparate locations(not at the sametime)Treatment arearestricted byapplicatorgeometryIntensities:1-10Treatment time:8min | Body Pads (max. 2pairs of conductivepads)local treatment onskeletal musclesno distancerestriction betweenconductible bodypadsIntensities: 1-99Treatment time: 1-30min | Minor difference,no impact onsafety andeffectiveness | |
| Optional LocalTreatment | Local applicator(B:PAD, B.SPOT,max. 2 applicatorsconnected to thedevice)Local treatment onskeletal muscles –to be used inseparate locations(not at the sametime)Treatment arearestricted byapplicatorgeometryIntensities:3-10Treatment time:8- 20min | Body Pads (max. 2pairs) plus FeetPad withIsoRocker2 plates for feet, 4conductive padsBoth feet andlower extremities,whole bodyapplicationpossibleIntensities: 1-99Treatment time: 1-30min | Minor difference,no impact onsafety andeffectiveness | |
| Model | B.BOXProfessionalB.BOX Classic | RIX | ||
| Weight | 1.3kg (B.BOXClassic)1.4kg (B.BOXProfessional) | 1.725kg | Minor difference,no impact onsafety andeffectiveness | |
| Dimensions | 32 x 32 x 7 cm | Ø360mm x 75mm(isoRockerenabled)Ø360mm x100.5mm(isoRockerdisabled) | Minor difference,no impact onsafety andeffectiveness | |
| PowerConsumption | Max 30 Watt | 5W | Minor difference,no impact onsafety andeffectiveness | |
| AC Adaptor - UL(UnderwritersLaboratories)Safety Mark | Image: UL Safety Mark E308578 | Image: UL Safety Mark E343720 | ||
| InputOutput | 100-240 VAC 50-60 Hz, 0.6A15 Vdc, 2.0AOptional 7.2 V Li-Ion battery | 100-240V,50/60Hz, 0.18A.5.0Vdc, 1.0A | Minor difference,no impact onsafety andeffectiveness | |
| Biocompatibility | Yes | Yes | Yes | |
| Number of outputmodes | 1 | 1 | 1 | |
| Number of outputchannels and ports | 2 for each | 2 (1 for foot, 1 forbody pads), 3output ports (2pairs of body padscan be run atsame time onsame channel) | 1 | |
| Software /Firmware /Microprocessorcontrolled | Yes | Yes | ||
| Voltage / CurrentLevel | 1-10 intensityindicator | 1-99 intensityindicator | Minor difference,no impact onsafety andeffectiveness | |
| Timer Range | 8-20 minutes | 1-60 minutes | Minor difference,no impact onsafety andeffectiveness | |
| Compliance withvoluntary standards | IEC60601-1IEC 60601-1-2EN 60601-1-6EN 62366EN 60601-1-11 | EN 60601-1EN 60601-1-2EN60601-1-11 | ||
| Compliance withEuropean Medicaldevice Directive(93/42/EEC) | Yes | Yes | ||
| Sterilization | Not provided sterile | Not providedsterile | Not providedsterile |
Table 12.1, BEMER Therapy Systems Substantial Equivalence Summary Table
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Usability:
A Usability study was conducted to proof that the intended users can identify the key functions of the device and to assess, that they can operate the device in a safe and effective manner based on their knowledge and following the directions for use in the device label.
The BEMER Therapy Systems usability study design follows FDA's human factors guidance for industry entitled, Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016). In summary, BEMER Therapy Systems, as labeled, are safe and effective in use by lay and professional users and therefore it is suitable for Over-The-Counter (OTC) use.
Substantial Equivalence:
The Bemer Therapy System is as safe and effective as its predicate device. BEMER therapy Systems have equivalent technology characteristics and similar principles of operation. The intended use is the same as its predicate device.
The differences between the BEMER Therapy Systems and its predicate device raise no new safety or effectiveness issues. Clinical performance data demonstrate that BEMER therapy Systems are as safe as the predicate device and it is suitable for Over-The-Counter (OTC).
Conclusion:
Summarized, all technical and performance data indicate that BEMER Therapy System are equivalent to the predicate device. Thus, BEMER Therapy Systems are substantially equivalent.
§ 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).