K Number
K231368
Device Name
Bemer Therapy System Evo
Manufacturer
Date Cleared
2023-06-09

(29 days)

Product Code
Regulation Number
890.5850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Description
BEMER therapy system Evo is a noninvasive physical medicine device that can be used as a supportive therapy to increase local blood circulation. BEMER Therapy System Evo improves 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 device is noninvasive, fully reusable (no disposable components such as electrodes), and has configurations allowing both patient/home and professional/office use. This submission is for the redesigned BEMER Therapy System Evo model including all previous applicators plus a new applicator, B.BED Evo. The device contains firmware that controls the user interface. It also contains the pulse generator, battery charger, audio and pushbutton controller.
More Information

Not Found

No
The summary describes a physical medicine device using electromagnetic stimulation with firmware for control, but there is no mention of AI or ML in the device description, intended use, or performance studies.

Yes
The device description and intended use state that it is used to temporarily increase local blood circulation and stimulate healthy muscles to improve and facilitate muscle performance, which are therapeutic actions.

No

The device description and intended use state that it temporarily increases local blood circulation and stimulates healthy muscles to improve and facilitate muscle performance. These are therapeutic actions, not diagnostic ones. Performance studies confirm measurements related to signal and magnetic flux output, but do not mention diagnostic metrics or capabilities.

No

The device description explicitly states it is a "noninvasive physical medicine device" that improves blood distribution via "electromagnetic stimulatory principles." It also mentions hardware components like a "pulse generator, battery charger, audio and pushbutton controller," and applicators. While it contains firmware, it is not solely software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The intended use is to temporarily increase local blood circulation and stimulate healthy muscles. These are physiological effects on the body, not diagnostic tests performed on samples taken from the body.
  • Device Description: The device is described as a "noninvasive physical medicine device" that uses electromagnetic stimulation. This aligns with a therapeutic or physical therapy device, not a diagnostic one.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
  • Performance Studies: The performance studies focus on the device's output (current, magnetic flux) and compliance with electrical, EMC, and biocompatibility standards, which are typical for therapeutic medical devices. There are no studies related to diagnostic accuracy (sensitivity, specificity, etc.).

In summary, the BEMER Therapy System Evo is a therapeutic medical device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

NGX

Device Description

BEMER therapy system Evo is a noninvasive physical medicine device that can be used as a supportive therapy to increase local blood circulation.

BEMER Therapy System Evo improves 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 device is noninvasive, fully reusable (no disposable components such as electrodes), and has configurations allowing both patient/home and professional/office use.

This submission is for the redesigned BEMER Therapy System Evo model including all previous applicators plus a new applicator, B.BED Evo.

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Healthy leg muscles.
Skeletal muscles.
Lower extremities and upper torso.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

patient/home and professional/office use.
OTC

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 Evo . console as input to the applicators
  • Magnetic flux output (uT) generated from B.BODY Evo, B.SPOT Evo, B.SIT Evi, B.BED ● Evo and B.PAD Evo applicators at all signal intensity input levels

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K151834, K210174

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 8, 2023

BEMER International AG % Prithul Bom Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K231368

Trade/Device Name: BEMER Therapy System Evo Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: May 11, 2023 Received: May 11, 2023

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 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

1

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 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-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 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,

Tushar Bansal -S

Tushar Bansal, PhD Acting Assistant Director THT5B3: 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

2

Indications for Use

510(k) Number (if known) K231368

Device Name BEMER Therapy System Evo

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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3

Date Prepared:08-Jun-2023
-----------------------------

I Submitter

BEMER International, AG
Austrasse 15
LIE-9495 Triesen, Liechtenstein
Phone: +423-792-7386

| Submitter Contact: | Sandra Schwarzenberger
Quality Director |
|---------------------------|--------------------------------------------|
| Submission Correspondent: | Paul Dryden
ProMedic, LLC |

II Device

Proprietary or Trade Name:BEMER Therapy Systems Evo
Common/Usual Name:Powered Muscle Stimulator
Classification Name:Stimulator, Muscle, Powered, For Muscle Conditioning
Regulation(21 CFR 890.5850)
Product Code:NGX

III Predicate Device:

Common/Usual Name:BEMER Classic Set and BEMER Pro-Set (K151834)
Classification Name:Powered Muscle Stimulator
RegulationStimulator, Muscle, Powered, For Muscle Conditioning
(21 CFR 890.5850)
Product Code:NGX

Secondary Predicate Device:

| Common/Usual Name: | BEMER Classic Set and BEMER Pro-Set (K210174)
B. Sit and B. Body applicators |
|----------------------|---------------------------------------------------------------------------------|
| Classification Name: | Powered Muscle Stimulator |
| Regulation | Stimulator, Muscle, Powered, For Muscle Conditioning
(21 CFR 890.5850) |
| Product Code: | NGX |

IV Device Description:

Device Description: IV

BEMER therapy system Evo is a noninvasive physical medicine device that can be used as a supportive therapy to increase local blood circulation.

BEMER Therapy System Evo improves 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 device is noninvasive, fully reusable (no disposable components such as electrodes), and has configurations allowing both patient/home and professional/office use.

This submission is for the redesigned BEMER Therapy System Evo model including all previous applicators plus a new applicator, B.BED Evo.

4

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

V Indications for Use:

  • 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 System Evo BEMER Therapy Systems
Subject Device | BEMER Therapy Systems
Predicate Device
K151834 | BEMER Therapy Systems
Applicator:
B.SIT and B.BODY
Secondary Predicate
K210174 |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Code(s) | Primary: Powered Muscle
Stimulator NGX 890.5850 | Primary: Powered Muscle
Stimulator NGX 890.5850 | Primary: Powered Muscle
Stimulator NGX 890.5850 |
| Indications for
Use | The BEMER therapy
System Evo is indicated:
To temporarily increase local
blood circulation in healthy
leg muscles.
To stimulate healthy muscles | The BEMER therapy
System is indicated:
To temporarily increase local
blood circulation in healthy
leg muscles.
To stimulate healthy muscles in | The BEMER therapy
System is indicated:
To temporarily increase local
blood circulation in healthy
leg muscles.
To stimulate healthy muscles
in order to improve and |
| Primary Mode of
Action | in order to improve and
facilitate muscle performance.
Non-invasive tissue
stimulation via magnetic field
induction | order to improve and facilitate
muscle performance.
Non-invasive tissue
stimulation via magnetic field
Induction | facilitate muscle performance.
Non-invasive tissue
stimulation via magnetic field
induction |
| Treat large and/or
multiple regions
Simultaneously | Yes
B. Spot Evo and B. Pad Evo
B. Grip Evo - holds B. Spot
B. Sit Evo
Application modules for local
treatments. Local treatment on
skeletal muscles. Treatment
area restricted by applicator
geometry.
B. Body Evo and B. Bed Evo
Lower extremities and upper
torso. Local treatment on
skeletal muscles.
Treatment area restricted by | Yes
B. Spot and B. Pad
B. Grip - holds B. Spot
Application modules for local
treatments. Local treatment on
skeletal muscles. Treatment
area restricted by applicator
geometry. | Yes
B. Sit
Application module for local
treatments. Local treatment
on skeletal muscles.
Treatment area restricted by
applicator geometry.
B. Body - Lower extremities
and upper torso. Local
treatment on skeletal muscles
Treatment area restricted by
applicator geometry |

Table 1: Comparison of Subject vs. Predicate

5

510(k) Summary Page 3 of 5

| | BEMER Therapy System Evo
Subject Device | BEMER Therapy Systems
Predicate Device
K151834 | BEMER Therapy Systems
Applicator:
B.SIT and B.BODY
Secondary Predicate
K210174 |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| | applicator geometry. | | |
| Multiple
Applicators | B. Spot Evo
B. Pad Evo
B. Grip Evo
B. Sit Evo
B. Body Evo
B. Bed Evo (new) | B. Spot
B. Pad
B. Grip | B. Sit
B. Body |
| Average Flux
density
(Applicator) | $\approx$ 35 μΤ το 50 μΤ (max. level)
B. Body Evo and B. Bed Evo | | $\approx$ 35 μΤ to 50 µT (max. level)
B. Body |
| | $\approx$ 100 to 150 μΤ (max. level)
B. Sit Evo, B. Pad Evo, B.
Grip Evo and B.Spot Evo | $\approx$ 100 to 150 μΤ (max. level)
B. Pad, B. Grip and B.Spot | $\approx$ 100 to 150 μΤ (max. level)
B. Sit |
| Power
Consumption
(System) | 30 Watt max. | 30 Watt max. | 30 Watt max. |
| Number of output
modes (System) | 1 | 1 | 1 |
| Number of output
channels and ports
(System) | 2 for each | 2 for each | 2 for each |
| Voltage / Current
Level | 1-3 intensity indicator | 1-10 intensity indicator | 1-10 intensity indicator |
| Timer Range | 8-20 minutes | 8-20 minutes | 8-20 minutes |
| Biocompatibility | Surface Contact, Intact skin,
permanent duration of use (>
30 days)
ISO 10993-5:2009
ISO 10993-10:2010 | Surface Contact, Intact skin,
permanent duration of use (>
30 days) | Surface Contact, Intact skin,
permanent duration of use (>
30 days) |
| Compliance with
voluntary standards | IEC 60601-1 | IEC60601-1 | IEC60601-1 |
| | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 |
| | EN 60601-1-6 | EN 60601-1-6 | EN 60601-1-6 |
| | EN 62366
EN 60601-1-11 | EN 62366
EN 60601-1-11 | EN 62366
EN 60601-1-11 |

VII Substantial Equivalence

Intended Use/ Indications for Use

The BEMER Therapy System Evo and its applicators have indications for use as the predicates, K151834 and K210174.

Technological Characteristics

The technology of the coils is identical to that of the predicate applicators. The coils of the B.Body Evo and B.Bed Evo have been redesigned but treat the same regions with the identical power out as the predicates, K151834 and K210174. Specific to the B.Bed Evo applicator has the same power outputs, average flux density, as the cleared B. Body Evo, K210174. It provides local stimulation of more superficial muscles to temporarily increase local blood flow while the other applicators are used for applications for deeper penetration and therefore are intended for a more targeted therapy.

6

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 Evo . console as input to the applicators
  • Magnetic flux output (uT) generated from B.BODY Evo, B.SPOT Evo, B.SIT Evi, B.BED ● Evo and B.PAD Evo applicators at all signal intensity input levels

Software

  • . Validation and Verification performed.
    Electrical / EMC

  • 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

Biocompatibilitv

  • Surface Contact, Intact Skin, Permanent duration of use. Evaluated with ISO 10993-5 2009 ● - Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity and ISO 10993-10 - 2010 - 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:

  • Updating the console, B.Box Evo to a new look ●
  • . Change in coil design for the B. Body Evo from a 6 coil configuration. Output is the same as the predicate B. Body, K210174
  • . Adding B. Bed Evo applicator which is a larger configuration of B. Body with the same 16 coil configuration and outputs.
  • . Limiting the intensity settings to 3 vs. 10 as in the predicate

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510(k) Summary Page 5 of 5

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 different 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 different 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 different safety concerns compared to the predicates, and is therefore substantially equivalent to the predicate devices.