BEMER Classic Set, BEMER Pro-Set

K151834 · Bemer Int AG · NGX · Feb 22, 2017 · Physical Medicine

Device Facts

• Record ID: K151834
• Device Name: BEMER Classic Set, BEMER Pro-Set
• Applicant: Bemer Int AG
• Product Code: NGX · Physical Medicine
• Decision Date: Feb 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

BEMER Therapy Systems are non-invasive physical medicine devices for home use. Systems consist of B.BOX console, signal applicators (B.PAD, B.SPOT), power pack, and B.SCAN indicator. Device operates via electromagnetic field induction to stimulate muscle tissue; induces microcurrents to improve local blood circulation and muscle activity. Operated by patients for self-use; treatment sessions typically last 8-20 minutes. Healthcare providers or patients use device to support muscle conditioning, improve contractile properties, and increase local blood flow. Benefits include temporary relief of muscle fatigue and improved muscle performance.

Clinical Evidence

Bench testing only. Compliance with IEC/EN 60601-1, 60601-1-2, 60601-1-11, and EN ISO 10993-1 standards confirmed. Usability study conducted per FDA human factors guidance (Feb 2016) demonstrated that lay and professional users can safely and effectively operate the device.

Technological Characteristics

Non-invasive electromagnetic stimulator. Uses magnetic field induction to generate microcurrents in tissue. Sinusoidal, monopolar pulsed waveform; 10-30Hz repetition rate; 10-33μS pulse duration; 35-100μT power density. Microprocessor-controlled. Powered by AC adapter or 7.2V Li-Ion battery. Not sterile. Compliant with IEC 60601-1, 60601-1-2, 60601-1-11, EN ISO 10993-1, EN ISO 13485, EN ISO 14971, and IEC/EN 62304.

Indications for Use

Indicated for healthy individuals to temporarily increase local blood circulation in leg muscles and to stimulate healthy muscles to improve/facilitate muscle performance.

Regulatory Classification

Identification

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

Predicate Devices

• Revitive IX (K143207)

Reference Devices

• Neotonus Model 1000 Muscle Stimulator System (K973929)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized representation of three human profiles facing to the right, stacked one behind the other, with flowing lines beneath them.

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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Fax: [phone] Registration Number: 30039102830
- Contact: BEMER International AG Sven Bieler, Fred Harms Austrasse 15 LIE-9495 Triesen, Liechtenstein Phone: [phone] Fax: [phone]

| Date of Submission: | February 22, 2017 |
|----------------------|---------------------------------------------------------------------------------|
| Proprietary Name(s): | BEMER Classic Set and BEMER Pro-Set |
| Common Name: | Powered Muscle Stimulator, Powered Muscle Stimulator for<br>Muscle 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,<br>General Requirements for Safety |
| IEC 60601-1-2:2014 | Medical Electrical Equipment, Part 1-2, General Requirement for<br>Safety. Electromagnetic Compatibility |
| IEC/EN 60601-1-4:2001 | Medical Electrical Equipment, Part 1-4, Collateral Standard:<br>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,<br>General requirements for basic safety and essential performance<br>–<br>Collateral Standard: Requirements for medical electrical<br>equipment and medical electrical systems used in the home<br>healthcare environment |
| IEC/EN 62366 | Medical devices - Application of usability engineering to medical<br>devices |
| EN ISO 10993-1:2009 | Biological Evaluation of Medical Devices Part 1: Evaluation and<br>Testing<br>(Overall plan and requirements established internally, specific<br>tests conducted by 3rd party, see Section 16) |
| General Compliance Standards | |
| EN ISO 13485:2012 | Medical Devices, Quality Management Systems, Requirements<br>for 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 Therapy<br>Systems | Revitive IX<br>(K143207) | Neotonus MS-101<br>Magnetic Muscle<br>Stim. System<br>(K973929)<br>Reference Device | Comments |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SUBJECT DEVICE | Predicate Device | | |
| Classification<br>Code(s) | Primary: Powered<br>Muscle Stimulator<br>NGX 890.5850 | Primary: Powered<br>Muscle Stimulator<br>NGX 890.5850 | Powered Muscle<br>Stimulator<br>IPF 890.5850 | |
| | | Secondary:<br>Transcutaneous<br>Nerve Stimulator<br>NUH 882.5890 | | |
| Indications for<br>Use | [Pending] The<br>BEMER therapy is<br>indicated:<br><br>To temporarily<br>increase local<br>blood circulation in<br>healthy leg<br>muscles.<br><br>- To stimulate<br>healthy<br>muscles in<br>order to<br>improve and<br>facilitate<br>muscle<br>performance. | To temporarily<br>increase local<br>blood circulation in<br>healthy leg<br>muscles.<br><br>- To stimulate<br>healthy<br>muscles in<br>order to<br>improve and<br>facilitate<br>muscle<br>performance.<br><br>- For temporary<br>relief of pain<br>associated<br>with sore and<br>aching<br>muscles in the<br>shoulder,<br>waist, back,<br>upper<br>extremities<br>(arms) and<br>lower<br>extremities<br>(legs) due to<br>strain from<br>exercise or<br>normal<br>household<br>duties. | The Neotonus MS-<br>101 Magnetic<br>Muscle Stimulator<br>System is intended<br>to be used under<br>medical<br>supervision for<br>adjunctive therapy<br>for the treatment of<br>medical diseases<br>and conditions.<br>The Neotonus MS-<br>101 is indicated for<br>use in stimulating<br>neuromuscular<br>tissues for bulk<br>muscle excitation<br>in the legs or arms<br>for rehabilitative<br>purposes.<br>Indications for Use<br>for Muscle<br>Stimulators:<br>Relaxation of<br>muscle spasms,<br>prevention or<br>retardation of<br>disuse atrophy,<br>increasing local<br>blood circulation,<br>muscle re-<br>education,<br>immediate post-<br>surgical stimulation<br>of calf muscles to<br>prevent venous<br>thrombosis,<br>maintaining or | |
| | BEMER | Revitive IX<br>(K143207) | Neotonus<br>(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: 20-53Hz<br>Body: 35-46Hz | 1-55Hz | Minor difference, no impact on safety and effectiveness |
| Single pulse duration | All accessories: 10 - 33μS | Foot:0.4 - 7.5µS<br>Body: 1.4 - 33.6µS | 18-1000µS | Minor difference, no impact on safety and effectiveness |
| Maximum Power density applied:: | All accessories: 35 - 100μT | Foot:<br>0.023 mA/cm2<br>Body:<br>0.082 mA/cm2 | 1-100% | Minor difference, no impact on safety and effectiveness |
| Maximum output voltage | N/A | @500Ω: 20-32V<br>@2kΩ: 95-118V<br>@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 body<br><br>All accessories:<br><5mA (acc. to IEC 60601-1) | Current directly applied to the patient's body:<br><br>@500Ω: 40-64mA<br>@2kΩ: 48-59mA<br>@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 Plan<br>Treatment | Local applicator<br>(B:PAD, B.SPOT,<br>max. 2 applicators<br>connected to the<br>device)<br><br>Local treatment on<br>skeletal muscles –<br>to be used in<br>separate locations<br>(not at the same<br>time)<br><br>Treatment area<br>restricted by<br>applicator<br>geometry<br><br>Intensities:1-10<br>Treatment time:<br>8min | Body Pads (max. 2<br>pairs of conductive<br>pads)<br><br>local treatment on<br>skeletal muscles<br><br>no distance<br>restriction between<br>conductible body<br>pads<br><br>Intensities: 1-99<br>Treatment time: 1-<br>30min | Minor difference,<br>no impact on<br>safety and<br>effectiveness | |
| Optional Local<br>Treatment | Local applicator<br>(B:PAD, B.SPOT,<br>max. 2 applicators<br>connected to the<br>device)<br><br>Local treatment on<br>skeletal muscles –<br>to be used in<br>separate locations<br>(not at the same<br>time)<br><br>Treatment area<br>restricted by<br>applicator<br>geometry<br><br>Intensities:3-10<br>Treatment time:<br>8- 20min | Body Pads (max. 2<br>pairs) plus Feet<br>Pad with<br>IsoRocker<br><br>2 plates for feet, 4<br>conductive pads<br><br>Both feet and<br>lower extremities,<br>whole body<br>application<br>possible<br><br>Intensities: 1-99<br>Treatment time: 1-<br>30min | Minor difference,<br>no impact on<br>safety and<br>effectiveness | |
| Model | B.BOX<br>Professional<br>B.BOX Classic | RIX | | |
| Weight | 1.3kg (B.BOX<br>Classic)<br>1.4kg (B.BOX<br>Professional) | 1.725kg | Minor difference,<br>no impact on<br>safety and<br>effectiveness | |
| Dimensions | 32 x 32 x 7 cm | Ø360mm x 75mm<br>(isoRocker<br>enabled)<br>Ø360mm x<br>100.5mm<br>(isoRocker<br>disabled) | Minor difference,<br>no impact on<br>safety and<br>effectiveness | |
| Power<br>Consumption | Max 30 Watt | 5W | Minor difference,<br>no impact on<br>safety and<br>effectiveness | |
| AC Adaptor - UL<br>(Underwriters<br>Laboratories)<br>Safety Mark | Image: UL Safety Mark E308578 | Image: UL Safety Mark E343720 | | |
| Input<br>Output | 100-240 VAC 50-<br>60 Hz, 0.6A<br>15 Vdc, 2.0A<br>Optional 7.2 V Li-<br>Ion battery | 100-240V,<br>50/60Hz, 0.18A.<br>5.0Vdc, 1.0A | | Minor difference,<br>no impact on<br>safety and<br>effectiveness |
| Biocompatibility | Yes | Yes | Yes | |
| Number of output<br>modes | 1 | 1 | 1 | |
| Number of output<br>channels and ports | 2 for each | 2 (1 for foot, 1 for<br>body pads), 3<br>output ports (2<br>pairs of body pads<br>can be run at<br>same time on<br>same channel) | 1 | |
| Software /<br>Firmware /<br>Microprocessor<br>controlled | Yes | Yes | | |
| Voltage / Current<br>Level | 1-10 intensity<br>indicator | 1-99 intensity<br>indicator | | Minor difference,<br>no impact on<br>safety and<br>effectiveness |
| Timer Range | 8-20 minutes | 1-60 minutes | | Minor difference,<br>no impact on<br>safety and<br>effectiveness |
| Compliance with<br>voluntary standards | IEC60601-1<br>IEC 60601-1-2<br>EN 60601-1-6<br>EN 62366<br>EN 60601-1-11 | EN 60601-1<br>EN 60601-1-2<br>EN60601-1-11 | | |
| Compliance with<br>European Medical<br>device Directive<br>(93/42/EEC) | Yes | Yes | | |
| Sterilization | Not provided sterile | Not provided<br>sterile | Not provided<br>sterile | |

#### 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.