(13 days)
Not Found
No
The description focuses on electromagnetic stimulation and firmware control, with no mention of AI or ML algorithms for data analysis, decision-making, or adaptive behavior.
Yes
The device is used to increase local blood circulation and stimulate healthy muscles to improve muscle performance, which are therapeutic functions.
No
The device description and intended use indicate that it is for therapeutic purposes (increasing blood circulation, stimulating muscles) rather than for diagnosing conditions.
No
The device description explicitly states it is a "family of noninvasive physical medicine devices" and mentions hardware components like "applicators," "consoles," "pulse generator," "battery charger," and "pushbutton controller." It also describes performance testing involving measurements of current and magnetic flux output from these hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device is applied externally to the body (healthy leg muscles, lower extremities, upper torso, skeletal muscles) to influence local blood circulation and stimulate muscles. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The device description focuses on physical effects. The mechanism of action described is via electromagnetic stimulatory principles to improve local blood distribution and stimulate muscles. This is a physical interaction with the body, not a diagnostic test performed on a sample.
- The performance testing described is related to physical output. The testing measures signal waveform current output and magnetic flux output, which are physical characteristics of the device's operation, not diagnostic performance metrics like sensitivity or specificity.
Therefore, this device falls under the category of a physical medicine device or a therapeutic device, not an In Vitro Diagnostic.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 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
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.
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 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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| For-Hire Transportation (SEE 49 U.S.C. Section 31132) | For-Hire Transportation (SEE 49 U.S.C. Section 31132) |
|---|---|
| -------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------- |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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.
Page 1 of 6
Date Prepared:
04-Feb-2021
I Submitter
BEMER International, AG Austrasse 15 LIE-9495 Triesen, Liechtenstein Phone: +423-399-3999 Fax: +423-399-3998
| 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.
4
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
Indications for Use:
The BEMER therapy systemin indications for use as cleared under K151834, remain unchanged.
Page 2 of 6
- 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
Systems
Applicator:
B. BODY
Subject Device | BEMER Therapy
Systems
Applicator:
B.SIT
Subject Device | BEMER Therapy
Systems
Applicator:
B.PAD
Predicate Device
K151834 | BEMER Therapy
Systems
Applicator:
B.SPOT
Predicate Device
K151834 |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Code(s) | Primary: Powered
Muscle Stimulator NGX
890.5850 | 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 is
indicated:
• To temporarily
increase local
blood circulation in
healthy leg
muscles.
• To stimulate healthy
muscles in order to
improve and
facilitate muscle
performance. | The BEMER therapy is
indicated:
• To temporarily
increase local blood
circulation in
healthy leg muscles.
• To stimulate healthy
muscles in order to
improve and
facilitate muscle
performance | The BEMER therapy
is indicated:
• To temporarily
increase local
blood circulation
in healthy leg
muscles.
• To stimulate healthy
muscles in order to
improve and facilitate
muscle performance. | The BEMER therapy
is indicated:
• 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
Applicator:
B. BODY
Subject Device | BEMER Therapy
Systems
Applicator:
B.SIT
Subject Device | BEMER Therapy
Systems
Applicator:
B.PAD
Predicate Device
K151834 | BEMER Therapy
Systems
Applicator:
B.SPOT
Predicate Device
K151834 |
| PRIMARY MODE
OF ACTION | Non-invasive tissue
stimulation via
magnetic field
induction | Non-invasive tissue
stimulation via
magnetic field
induction | Non-invasive tissue
stimulation via
magnetic field
induction | Non-invasive tissue
stimulation via
magnetic field
induction |
| Treatment of large
and/or multiple
regions
simultaneously | X | X | X | X |
| Enlarged | B.BODY
Basic Plan Treatment
Intensities: 1-6
Treatment time:
8 min | B.SIT
Program settings
P1-P3
Intensities: 1-10
Treatment time:
8-20min | B.PAD
Program settings
P1-P3
Intensities: 1-10
Treatment time:
8- 20min | B.SPOT
Program settings
P1-P3
Intensities: 1-10
Treatment time:
8- 20min |
| | Lower extremities
and upper torso | Application module for
local treatments. | Application module for
local treatments. | Application module
for local treatments. |
| Local | Local applicator (max.
2 applicators)
Local treatment
skeletal muscles
treatment area
restricted by applicator
geometry
Intensities:1-10
Treatment time:
8 -20min | Local applicator
Local treatment on
skeletal muscles
treatment area
restricted by
applicator geometry
Intensities:1-10
Treatment time:
8- 20min | Local applicator (max.
2 applicators)
Local treatment on
skeletal muscles
treatment area
restricted by
applicator geometry
Intensities: 1-10
Treatment time:
8-20min | Local applicator
(max. 2 applicators)
Local treatment on
skeletal muscles
treatment area
restricted by
applicator geometry
Intensities: 1-10
Treatment time:
8-20min |
| (System Pro can
use 2 different
applicators) | | | | |
| (System Classic
can use only two
B. BODY's) | | | | |
| Enlarged + Local | B. BODY plus local
applicator (1 of each)
Lower extremities and
upper torso plus local
application on skeletal
muscles | B.SIT plus local
applicator | B.PAD plus local
applicator | B.SPOT plus local
applicator |
| Model (System) | B.BOX
Professional B.BOX
Classic | B.BOX
Professional B.BOX
Classic | B.BOX
Professional
B.BOX Classic | B.BOX
Professional
B.BOX Classic |
| Weight | System:
1.3kg(B.BOX
Classic)
1.4kg(B.BOX
Professional) | System:
1.3kg(B.BOX
Classic)
1.4kg(B.BOX
Professional) | System:
1.3kg(B.BOX
Classic)
1.4kg(B.BOX
Professional) | System:
1.3kg(B.BOX
Classic)
1.4kg (B.BOX
Professional) |
| | Applicator:
2 kg
(B. BODY Classic &
Professional) | Applicator:
1.6 kg (B. SIT | Applicator:
0.38kg (B.PAD) | Applicator:
0.3kg (B. SPOT) |
| | BEMER Therapy
Systems
Applicator:
B. BODY
Subject Device | BEMER Therapy
Systems
Applicator:
B.SIT
Subject Device | BEMER Therapy
Systems
Applicator:
B.PAD
Predicate Device
K151834 | BEMER Therapy
Systems
Applicator:
B.SPOT
Predicate Device
K151834 |
| Dimensions
(Applicator) | B. BODY Classic &
Professional
180 x 60 x 2 cm | B.SIT
45 x 37 x 4 cm | B.PAD
111 x 13 x 1,5 cm | B. SPOT
13 x 13 x 3,0 cm |
| Average Flux
density (Applicator) | $\approx$ 35 µT (max. level)
(B. BODY Classic &
Professional) | $\approx$ 100 µT (max. level) | $\approx$ 100 µT (max. level) | $\approx$ 100 µT (max. level) |
| Average Flux
density plus
(Applicator) | $\approx$ 50 µT (max. level)
(B. BODY Classic &
Professional) | $\approx$ 150 µT (max. level) | $\approx$ 150 µT (max. level) | $\approx$ 150 µT (max. level) |
| Power
Consumption
(System) | 30 Watt max. | 30 Watt max. | 30 Watt max. | 30 Watt max. |
| Input (System) | 100-240 VAC 50-60
Hz, 0.6A | 100-240 VAC 50-60
Hz, 0.6A | 100-240 VAC 50-60
Hz, 0.6A | 100-240 VAC 50-60
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
battery | Optional 7.2 V Li- Ion
battery | Optional 7.2 V Li- Ion
battery | Optional 7.2 V Li- Ion battery |
| Biocompatibility | Yes | Yes | Yes | Yes |
| Number of output
modes (System) | 1 | 1 | 1 | 1 |
| Number of output
channels and ports
(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.
6
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 /
Firmware /
Microprocessor
| controlled | Yes | Yes | Yes | Yes |
|---|---|---|---|---|
| Voltage / Current | ||||
| Level | 1-10 intensity indicator | 1-10 intensity indicator | 1-10 intensity | |
| indicator | 1-10 intensity | |||
| indicator | ||||
| Timer Range | 8-20 minutes | 8-20 minutes | 8-20 minutes | 8-20 minutes |
| Compliance with | ||||
| voluntary standards | IEC60601-1 | |||
| IEC 60601-1-2 | ||||
| EN 60601-1-6 | ||||
| EN 62366 | ||||
| EN 60601-1-11 | IEC60601-1 | |||
| IEC 60601-1-2 | ||||
| EN 60601-1-6 | ||||
| EN 62366 | ||||
| EN 60601-1-11 | IEC60601-1 | |||
| IEC 60601-1-2 | ||||
| EN 60601-1-6 | ||||
| EN 62366 | ||||
| EN 60601-1-11 | IEC60601-1 | |||
| IEC 60601-1-2 | ||||
| EN 60601-1-6 | ||||
| EN 62366 | ||||
| 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.