BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set

K210174 · Bemer Int AG · NGX · Feb 4, 2021 · Physical Medicine

Device Facts

• Record ID: K210174
• Device Name: BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set
• Applicant: Bemer Int AG
• Product Code: NGX · Physical Medicine
• Decision Date: Feb 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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 noninvasive physical medicine devices using electromagnetic field induction to stimulate tissue. The system consists of a control console (B.BOX) and various applicators (B.BODY, B.SIT, B.PAD, B.SPOT). The device takes electrical input (100-240 VAC) and transforms it via a pulse generator into a magnetic field output delivered through the applicators to the user's body. It is used in both home and professional/office environments by patients or clinicians. The healthcare provider or patient selects intensity levels (1-10) and treatment times (8-20 minutes) via the console interface. The output is intended to increase local blood circulation and facilitate muscle performance. The system is reusable with no disposable components.

Clinical Evidence

Bench testing only. Performance testing included measurements of signal waveform current output (AC RMS in mA) and magnetic flux output (µT) at all intensity levels (1-10). Biocompatibility testing was conducted per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization). Electrical safety and EMC testing were performed per IEC 60601-1, IEC 60601-1-2, EN 60601-1-11, EN 60601-1-6, and EN 62366.

Technological Characteristics

Noninvasive electromagnetic stimulator. System includes B.BOX console and applicators (B.BODY, B.SIT). Powered by 100-240 VAC or optional 7.2V Li-ion battery. Output: magnetic field induction. Flux density: ~35-150 µT depending on applicator. Compliance: IEC 60601-1, IEC 60601-1-2, EN 60601-1-11, EN 60601-1-6, EN 62366. Biocompatibility: ISO 10993-5, ISO 10993-10. Not provided sterile.

Indications for Use

Indicated for healthy individuals to temporarily increase local blood circulation in leg muscles and to stimulate healthy muscles to improve and 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

• BEMER Classic Set and BEMER Pro-Set (K151834)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 4, 2021

Bemer INT. AG % Prithul Bom Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K210174

Trade/Device Name: BEMER Classic Set and BEMER Pro-Set Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: January 21, 2021 Received: January 22, 2021

Dear Prithul Bom:

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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K210174

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)

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__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for BEMER Group. The word "BEMER" is written in a stylized font, with the letters in gray except for the "M", which is in orange. To the right of "BEMER", the word "GROUP" is written in a smaller, orange font.

K210174

Page 1 of 6

#### Date Prepared:

04-Feb-2021

#### I Submitter

BEMER International, AG Austrasse 15 LIE-9495 Triesen, Liechtenstein Phone: [phone] Fax: [phone]

| Submitter Contact: | Sandra Schwarzenberger |
|--------------------|------------------------|
| | Quality Director |

| Submission Correspondent: | Paul Dryden |
|---------------------------|---------------|
| | ProMedic, LLC |

#### II Device

| Proprietary or Trade Name: | BEMER Classic Set and BEMER Pro-Set |
|----------------------------|------------------------------------------------------|
| Common/Usual Name: | Powered Muscle Stimulator |
| Classification Name: | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Regulation | (21 CFR 890.5850) |
| Regulatory Class: | II |
| Product Code: | NGX |

| III | Predicate Device: | BEMER Classic Set and BEMER Pro-Set (K151834) |
|-----|-------------------|-----------------------------------------------|
|-----|-------------------|-----------------------------------------------|

#### IV 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 systems improve local blood distribution via electromagnetic stimulatory principles. The indications for use allow application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance.

The BEMER devices are noninvasive, fully reusable (no disposable components such as electrodes), and have configurations allowing both patient/home and professional/office use.

This submission is specifically requesting to add the applicators, B.BODY and B.SIT to the already cleared BEMER Therapy System.

The device contains firmware that controls the user interface. It also contains that controls the pulse generator, battery charger, audion and pushbutton controller.

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Image /page/4/Picture/0 description: The image shows the logo for BEMER Group. The word "BEMER" is written in a sans-serif font, with the letters in gray except for the "M", which is in orange. To the right of "BEMER" is the word "GROUP", also in orange and in a smaller font size.

V

K210174

# Indications for Use:

The BEMER therapy systemin indications for use as cleared under K151834, remain unchanged.

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- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance

Environments of use: OTC (identical to K151834).

#### VI Comparison of Technological Characteristics and Performance with the Predicate

Table 1 below provides the summarized equivalence comparison of general intended uses/actions, specific indications for use, equivalence of key clinical and technical features between subject and predicate devices, along with a full listing of technical and conformance specifications.

| | BEMER Therapy<br>Systems<br>Applicator:<br>B. BODY<br>Subject Device | BEMER Therapy<br>Systems<br>Applicator:<br>B.SIT<br>Subject Device | BEMER Therapy<br>Systems<br>Applicator:<br>B.PAD<br>Predicate Device<br>K151834 | BEMER Therapy<br>Systems<br>Applicator:<br>B.SPOT<br>Predicate Device<br>K151834 |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification<br>Code(s) | Primary: Powered<br>Muscle Stimulator NGX<br>890.5850 | Primary: Powered<br>Muscle Stimulator<br>NGX 890.5850 | Primary: Powered<br>Muscle Stimulator<br>NGX 890.5850 | Primary: Powered<br>Muscle Stimulator<br>NGX 890.5850 |
| Indications for<br>Use | The BEMER therapy is<br>indicated:<br>• To temporarily<br>increase local<br>blood circulation in<br>healthy leg<br>muscles.<br>• To stimulate healthy<br>muscles in order to<br>improve and<br>facilitate muscle<br>performance. | The BEMER therapy is<br>indicated:<br>• To temporarily<br>increase local blood<br>circulation in<br>healthy leg muscles.<br>• To stimulate healthy<br>muscles in order to<br>improve and<br>facilitate muscle<br>performance | The BEMER therapy<br>is indicated:<br>• To temporarily<br>increase local<br>blood circulation<br>in healthy leg<br>muscles.<br>• To stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance. | The BEMER therapy<br>is indicated:<br>• To temporarily<br>increase local<br>blood circulation<br>in healthy leg<br>muscles.<br>• To stimulate<br>healthy muscles in<br>order to improve<br>and facilitate<br>muscle<br>performance. |
| | BEMER Therapy<br>Systems<br>Applicator:<br>B. BODY<br>Subject Device | BEMER Therapy<br>Systems<br>Applicator:<br>B.SIT<br>Subject Device | BEMER Therapy<br>Systems<br>Applicator:<br>B.PAD<br>Predicate Device<br>K151834 | BEMER Therapy<br>Systems<br>Applicator:<br>B.SPOT<br>Predicate Device<br>K151834 |
| PRIMARY MODE<br>OF ACTION | Non-invasive tissue<br>stimulation via<br>magnetic field<br>induction | Non-invasive tissue<br>stimulation via<br>magnetic field<br>induction | Non-invasive tissue<br>stimulation via<br>magnetic field<br>induction | Non-invasive tissue<br>stimulation via<br>magnetic field<br>induction |
| Treatment of large<br>and/or multiple<br>regions<br>simultaneously | X | X | X | X |
| Enlarged | B.BODY<br>Basic Plan Treatment<br>Intensities: 1-6<br>Treatment time:<br>8 min | B.SIT<br>Program settings<br>P1-P3<br>Intensities: 1-10<br>Treatment time:<br>8-20min | B.PAD<br>Program settings<br>P1-P3<br>Intensities: 1-10<br>Treatment time:<br>8- 20min | B.SPOT<br>Program settings<br>P1-P3<br>Intensities: 1-10<br>Treatment time:<br>8- 20min |
| | Lower extremities<br>and upper torso | Application module for<br>local treatments. | Application module for<br>local treatments. | Application module<br>for local treatments. |
| Local | Local applicator (max.<br>2 applicators)<br>Local treatment<br>skeletal muscles<br>treatment area<br>restricted by applicator<br>geometry<br>Intensities:1-10<br>Treatment time:<br>8 -20min | Local applicator<br>Local treatment on<br>skeletal muscles<br>treatment area<br>restricted by<br>applicator geometry<br>Intensities:1-10<br>Treatment time:<br>8- 20min | Local applicator (max.<br>2 applicators)<br>Local treatment on<br>skeletal muscles<br>treatment area<br>restricted by<br>applicator geometry<br>Intensities: 1-10<br>Treatment time:<br>8-20min | Local applicator<br>(max. 2 applicators)<br>Local treatment on<br>skeletal muscles<br>treatment area<br>restricted by<br>applicator geometry<br>Intensities: 1-10<br>Treatment time:<br>8-20min |
| (System Pro can<br>use 2 different<br>applicators) | | | | |
| (System Classic<br>can use only two<br>B. BODY's) | | | | |
| Enlarged + Local | B. BODY plus local<br>applicator (1 of each)<br>Lower extremities and<br>upper torso plus local<br>application on skeletal<br>muscles | B.SIT plus local<br>applicator | B.PAD plus local<br>applicator | B.SPOT plus local<br>applicator |
| Model (System) | B.BOX<br>Professional B.BOX<br>Classic | B.BOX<br>Professional B.BOX<br>Classic | B.BOX<br>Professional<br>B.BOX Classic | B.BOX<br>Professional<br>B.BOX Classic |
| Weight | System:<br>1.3kg(B.BOX<br>Classic)<br>1.4kg(B.BOX<br>Professional) | System:<br>1.3kg(B.BOX<br>Classic)<br>1.4kg(B.BOX<br>Professional) | System:<br>1.3kg(B.BOX<br>Classic)<br>1.4kg(B.BOX<br>Professional) | System:<br>1.3kg(B.BOX<br>Classic)<br>1.4kg (B.BOX<br>Professional) |
| | Applicator:<br>2 kg<br>(B. BODY Classic &<br>Professional) | Applicator:<br>1.6 kg (B. SIT | Applicator:<br>0.38kg (B.PAD) | Applicator:<br>0.3kg (B. SPOT) |
| | BEMER Therapy<br>Systems<br>Applicator:<br>B. BODY<br>Subject Device | BEMER Therapy<br>Systems<br>Applicator:<br>B.SIT<br>Subject Device | BEMER Therapy<br>Systems<br>Applicator:<br>B.PAD<br>Predicate Device<br>K151834 | BEMER Therapy<br>Systems<br>Applicator:<br>B.SPOT<br>Predicate Device<br>K151834 |
| Dimensions<br>(Applicator) | B. BODY Classic &<br>Professional<br>180 x 60 x 2 cm | B.SIT<br>45 x 37 x 4 cm | B.PAD<br>111 x 13 x 1,5 cm | B. SPOT<br>13 x 13 x 3,0 cm |
| Average Flux<br>density (Applicator) | $\approx$ 35 µT (max. level)<br>(B. BODY Classic &<br>Professional) | $\approx$ 100 µT (max. level) | $\approx$ 100 µT (max. level) | $\approx$ 100 µT (max. level) |
| Average Flux<br>density plus<br>(Applicator) | $\approx$ 50 µT (max. level)<br>(B. BODY Classic &<br>Professional) | $\approx$ 150 µT (max. level) | $\approx$ 150 µT (max. level) | $\approx$ 150 µT (max. level) |
| Power<br>Consumption<br>(System) | 30 Watt max. | 30 Watt max. | 30 Watt max. | 30 Watt max. |
| Input (System) | 100-240 VAC 50-60<br>Hz, 0.6A | 100-240 VAC 50-60<br>Hz, 0.6A | 100-240 VAC 50-60<br>Hz, 0.6A | 100-240 VAC 50-60<br>Hz, 0.6A |
| | 12-15.1 VDC, 2.0 A | 12-15.1 VDC, 2.0 A | 12-15.1 VDC, 2.0 A | 12-15.1 VDC, 2.0 A |
| Output (System) | Optional 7.2 V Li- Ion<br>battery | Optional 7.2 V Li- Ion<br>battery | Optional 7.2 V Li- Ion<br>battery | Optional 7.2 V Li- Ion battery |
| Biocompatibility | Yes | Yes | Yes | Yes |
| Number of output<br>modes (System) | 1 | 1 | 1 | 1 |
| Number of output<br>channels and ports<br>(System) | 2 for each | 2 for each | 2 for each | 2 for each |

#### Table 1: Comparison of Subject vs. Predicate

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Image /page/5/Picture/0 description: The image shows the Bemer Group logo. The word "Bemer" is written in a sans-serif font, with the letters in gray except for the "M", which is in orange. To the right of "Bemer" is the word "Group", also in orange, but in a smaller font.

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Image /page/6/Picture/0 description: The image shows the logo for BEMER Group. The word "BEMER" is in gray, except for the "M" which is in orange. To the right of the word "BEMER" is the word "GROUP" in orange.

| Software /<br>Firmware /<br>Microprocessor<br>controlled | Yes | Yes | Yes | Yes |
|----------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Voltage / Current<br>Level | 1-10 intensity indicator | 1-10 intensity indicator | 1-10 intensity<br>indicator | 1-10 intensity<br>indicator |
| Timer Range | 8-20 minutes | 8-20 minutes | 8-20 minutes | 8-20 minutes |
| 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 | IEC60601-1<br>IEC 60601-1-2<br>EN 60601-1-6<br>EN 62366<br>EN 60601-1-11 | IEC60601-1<br>IEC 60601-1-2<br>EN 60601-1-6<br>EN 62366<br>EN 60601-1-11 | IEC60601-1<br>IEC 60601-1-2<br>EN 60601-1-6<br>EN 62366<br>EN 60601-1-11 |
| Sterilization | Not provided sterile | Not provided sterile | Not provided sterile | Not provided sterile |

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Image /page/7/Picture/0 description: The image shows the logo for BEMER Group. The word "BEMER" is written in gray, with the "M" stylized as an orange line. To the right of "BEMER" is the word "GROUP", also in gray, but in a smaller font size.

#### VII Substantial Equivalence

The B.BODY and B.SIT applicators have the same indications for use as the predicate, K151834.

### Intended Use/ Indications for Use

The B.BODY and B.SIT applicators can only be used with the predicate B/BOX, K151834. They are accessories to the predicate and therefore have the same indications for use, population and use environments as the predicate, K151834.

### Technological Characteristics

The technology of the coils is identical to that of the predicate applicators. The output is the same or less as the predicate. K151834. Specific to the B.BODY applicator having lower power outputs, average flux density, relative to the other applicators as this applicator provides local stimulation of more superficial muscles to temporarily increase local blood flow. The other applicators are used for applications for deeper penetration and therefore are intended for a more targeted therapy.

#### Principles of Operation

The principle of operation is identical to the predicate, K151834.

#### Non-clinical Testing

Performance testing demonstrated that the subject applicators performed equivalent to the predicate applicators. Testing included:

Performance testing involved multiple measurements of:

- BEMER signal waveform current output (AC RMS in mA) generated from B.BOX Classic ● and Professional consoles as input to the applicators
- magnetic flux output (uT) generated from B.BODY, B.SPOT, B.SIT and B.PAD applicators ● at all signal intensity input levels 1-10

Software

- Unchanged .
### Electrical / EMC

- Unchanged but evaluated under
- 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 Disturbances - Requirements And Tests
- EN 60601-1-11 - Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment
- EN 60601-1-6 Medical Electrical Equipment Part 1-6: General Requirements For ● Basic Safety And Essential Performance - Collateral Standard: Usability
- . EN 62366 - Medical devices - Part 1: Application of usability engineering to medical devices

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Image /page/8/Picture/2 description: The image shows the logo for BEMER Group. The word "BEMER" is written in gray, blocky letters, with the "M" being stylized in orange. To the right of "BEMER" is the word "GROUP" in smaller, gray letters.

Biocompatibility

- 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

### Discussion of Differences

The differences between the proposed and predicate device are solely related to the addition of addition of the B.BODY and B.SIT accessories. The devices themselves are identical in hardware and software. Specific to the B.BODY applicator having lower power outputs, average flux density, relative to the other applicators as this applicator provides local stimulation of more superficial muscles to temporarily increase local blood flow. The other applicators are used for applications for deeper penetration and therefore are intended for a more targeted therapy.

These changes do not alter the indications for use, patient population, environments of use, technological characteristics, contraindications, or performance specifications. The differences do not raise new concerns of safety or effectiveness.

### Substantial Equivalence Conclusion

The changes to this device do not alter the indications for use, patient population, environments of use, technological characteristics, contraindications, or performance specifications. The differences do not raise new concerns of safety or effectiveness.

BEMER International, AG has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device does not raise any new safety concerns compared to the predicates.