(13 days)
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance
BEMER therapy systems are a family of noninvasive physical medicine devices that can be used as a supportive therapy to increase local blood circulation. BEMER 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.
The provided text is a 510(k) premarket notification document for a medical device, the BEMER Classic Set and BEMER Pro-Set, specifically requesting to add new applicators (B.BODY and B.SIT) to an already cleared system.
This document does not contain information about a study proving the device meets acceptance criteria related to a diagnostic AI or imaging-based device. The context is for a powered muscle stimulator. Therefore, the questions about acceptance criteria for AI algorithms, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and effect sizes are not applicable to this document's content.
The document focuses on demonstrating substantial equivalence to a predicate device (K151834) for new accessories (applicators B.BODY and B.SIT). The "acceptance criteria" here are based on similarity to the predicate device and compliance with relevant electrical safety, EMC, and biocompatibility standards.
Here's a breakdown of the relevant information from the document, tailored as much as possible to the spirit of your request, but acknowledging the difference in device type:
Device Type: Powered Muscle Stimulator (Non-invasive tissue stimulation via magnetic field induction)
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.
Instead of "Acceptance Criteria for AI Performance," the document discusses "Substantial Equivalence" to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance (as inferred from "Comparison of Technological Characteristics" and "Non-clinical Testing"):
| Characteristic / "Acceptance Criteria" (Predicate Baseline) | Subject Device (New Applicators: B.BODY & B.SIT) Performance | Justification/Comment |
|---|---|---|
| Classification Code (Primary: NGX 890.5850) | Same (NGX 890.5850) | Substantially Equivalent |
| Indications for Use | Same as predicate | Substantially Equivalent |
| Primary Mode of Action (Non-invasive tissue stimulation via magnetic field induction) | Same | Substantially Equivalent |
| Treatment of large and/or multiple regions simultaneously | Yes | Substantially Equivalent |
| Intensity Settings (1-10) | B.BODY: 1-6 (Basic Plan Treatment); B.SIT: 1-10 | B.BODY has lower max intensity as it's for superficial muscles |
| Treatment Time (8-20 minutes) | B.BODY: 8 min; B.SIT: 8-20 min | Substantially Equivalent for B.SIT. B.BODY is fixed 8 min. |
| Average Flux Density (max. level) | B.BODY: ≈ 35 µT (Basic), ≈ 50 µT (Plus); B.SIT: ≈ 100 µT (Basic), ≈ 150 µT (Plus) | B.BODY is lower than predicate (100/150 µT) due to superficial target. B.SIT is same. |
| Power Consumption (System) (30 Watt max.) | Same (30 Watt max.) | Substantially Equivalent |
| Input/Output (System) | Same (100-240 VAC 50-60 Hz, 0.6A; 12-15.1 VDC, 2.0A; Optional 7.2 V Li-Ion battery) | Substantially Equivalent |
| Biocompatibility | Yes (tested to ISO 10993-5, ISO 10993-10) | Meets standards |
| Number of output modes (1) | Same (1) | Substantially Equivalent |
| Number of output channels/ports (2 for each) | Same (2 for each) | Substantially Equivalent |
| Software/Firmware/Microprocessor controlled | Yes (Unchanged from predicate) | No new concerns |
| Timer Range (8-20 minutes) | Same | Substantially Equivalent |
| Compliance with voluntary standards (IEC 60601-1, IEC 60601-1-2, EN 60601-1-6, EN 62366, EN 60601-1-11) | Yes (Unchanged but evaluated under these standards for new design) | Meets standards |
| Sterilization (Not provided sterile) | Same (Not provided sterile) | Substantially Equivalent |
| Performance Testing (Signal waveform current output, magnetic flux output) | Performance testing demonstrated equivalence. | Data supports equivalence, though specific values not detailed beyond max flux density. |
2. Sample Size and Data Provenance:
- This document describes non-clinical performance testing of electrical and magnetic outputs, not a clinical study with human subjects or a test set of patient data.
- Therefore, concepts like "sample size used for the test set" (in the context of patient data) and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are not applicable. The testing was laboratory-based, comparing the new applicators' performance characteristics to the already cleared predicate.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable. Ground truth in the context of AI/medical imaging refers to expert interpretation of patient data. This document describes performance validation of physical device characteristics against engineering specifications and predicate device performance. No expert human interpretation of medical images or patient outcomes data for ground truth establishment is mentioned or required for this type of device and submission.
4. Adjudication Method:
- Not applicable. This refers to methods for resolving discrepancies in expert ground truth for medical data. Not relevant here.
5. MRMC Comparative Effectiveness Study:
- Not applicable. This is a study design for evaluating the impact of AI on human reader performance. This submission is for a physical therapy device, not a diagnostic AI system, and does not involve human readers interpreting AI output.
6. Standalone Performance (Algorithm Only):
- Not applicable. This relates to AI algorithm performance without human intervention. The BEMER device is a physical therapy device; there is no "algorithm only" performance in the sense of an AI model's output.
7. Type of Ground Truth Used:
- For this device, the "ground truth" (or basis for comparison) is the technical specifications and measurable electromagnetic outputs of the predicate device, along with adherence to recognized international standards for medical electrical equipment (e.g., IEC 60601 series, ISO 10993 series). No patient pathology or outcomes data is used as "ground truth" for this type of submission.
8. Sample Size for the Training Set:
- Not applicable. There is no AI training set involved in this 510(k) submission for a physical therapy device.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, no training set or its ground truth establishment is relevant to this document.
{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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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 TherapySystemsApplicator:B. BODYSubject Device | BEMER TherapySystemsApplicator:B.SITSubject Device | BEMER TherapySystemsApplicator:B.PADPredicate DeviceK151834 | BEMER TherapySystemsApplicator:B.SPOTPredicate DeviceK151834 | |
|---|---|---|---|---|
| ClassificationCode(s) | Primary: PoweredMuscle Stimulator NGX890.5850 | Primary: PoweredMuscle StimulatorNGX 890.5850 | Primary: PoweredMuscle StimulatorNGX 890.5850 | Primary: PoweredMuscle StimulatorNGX 890.5850 |
| Indications forUse | The BEMER therapy isindicated:• To temporarilyincrease localblood circulation inhealthy legmuscles.• To stimulate healthymuscles in order toimprove andfacilitate muscleperformance. | The BEMER therapy isindicated:• To temporarilyincrease local bloodcirculation inhealthy leg muscles.• To stimulate healthymuscles in order toimprove andfacilitate muscleperformance | The BEMER therapyis indicated:• To temporarilyincrease localblood circulationin healthy legmuscles.• To stimulate healthymuscles in order toimprove and facilitatemuscle performance. | The BEMER therapyis indicated:• To temporarilyincrease localblood circulationin healthy legmuscles.• To stimulatehealthy muscles inorder to improveand facilitatemuscleperformance. |
| BEMER TherapySystemsApplicator:B. BODYSubject Device | BEMER TherapySystemsApplicator:B.SITSubject Device | BEMER TherapySystemsApplicator:B.PADPredicate DeviceK151834 | BEMER TherapySystemsApplicator:B.SPOTPredicate DeviceK151834 | |
| PRIMARY MODEOF ACTION | Non-invasive tissuestimulation viamagnetic fieldinduction | Non-invasive tissuestimulation viamagnetic fieldinduction | Non-invasive tissuestimulation viamagnetic fieldinduction | Non-invasive tissuestimulation viamagnetic fieldinduction |
| Treatment of largeand/or multipleregionssimultaneously | X | X | X | X |
| Enlarged | B.BODYBasic Plan TreatmentIntensities: 1-6Treatment time:8 min | B.SITProgram settingsP1-P3Intensities: 1-10Treatment time:8-20min | B.PADProgram settingsP1-P3Intensities: 1-10Treatment time:8- 20min | B.SPOTProgram settingsP1-P3Intensities: 1-10Treatment time:8- 20min |
| Lower extremitiesand upper torso | Application module forlocal treatments. | Application module forlocal treatments. | Application modulefor local treatments. | |
| Local | Local applicator (max.2 applicators)Local treatmentskeletal musclestreatment arearestricted by applicatorgeometryIntensities:1-10Treatment time:8 -20min | Local applicatorLocal treatment onskeletal musclestreatment arearestricted byapplicator geometryIntensities:1-10Treatment time:8- 20min | Local applicator (max.2 applicators)Local treatment onskeletal musclestreatment arearestricted byapplicator geometryIntensities: 1-10Treatment time:8-20min | Local applicator(max. 2 applicators)Local treatment onskeletal musclestreatment arearestricted byapplicator geometryIntensities: 1-10Treatment time:8-20min |
| (System Pro canuse 2 differentapplicators) | ||||
| (System Classiccan use only twoB. BODY's) | ||||
| Enlarged + Local | B. BODY plus localapplicator (1 of each)Lower extremities andupper torso plus localapplication on skeletalmuscles | B.SIT plus localapplicator | B.PAD plus localapplicator | B.SPOT plus localapplicator |
| Model (System) | B.BOXProfessional B.BOXClassic | B.BOXProfessional B.BOXClassic | B.BOXProfessionalB.BOX Classic | B.BOXProfessionalB.BOX Classic |
| Weight | System:1.3kg(B.BOXClassic)1.4kg(B.BOXProfessional) | System:1.3kg(B.BOXClassic)1.4kg(B.BOXProfessional) | System:1.3kg(B.BOXClassic)1.4kg(B.BOXProfessional) | System:1.3kg(B.BOXClassic)1.4kg (B.BOXProfessional) |
| Applicator:2 kg(B. BODY Classic &Professional) | Applicator:1.6 kg (B. SIT | Applicator:0.38kg (B.PAD) | Applicator:0.3kg (B. SPOT) | |
| BEMER TherapySystemsApplicator:B. BODYSubject Device | BEMER TherapySystemsApplicator:B.SITSubject Device | BEMER TherapySystemsApplicator:B.PADPredicate DeviceK151834 | BEMER TherapySystemsApplicator:B.SPOTPredicate DeviceK151834 | |
| Dimensions(Applicator) | B. BODY Classic &Professional180 x 60 x 2 cm | B.SIT45 x 37 x 4 cm | B.PAD111 x 13 x 1,5 cm | B. SPOT13 x 13 x 3,0 cm |
| Average Fluxdensity (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 Fluxdensity 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) |
| PowerConsumption(System) | 30 Watt max. | 30 Watt max. | 30 Watt max. | 30 Watt max. |
| Input (System) | 100-240 VAC 50-60Hz, 0.6A | 100-240 VAC 50-60Hz, 0.6A | 100-240 VAC 50-60Hz, 0.6A | 100-240 VAC 50-60Hz, 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- Ionbattery | Optional 7.2 V Li- Ionbattery | Optional 7.2 V Li- Ionbattery | Optional 7.2 V Li- Ion battery |
| Biocompatibility | Yes | Yes | Yes | Yes |
| Number of outputmodes (System) | 1 | 1 | 1 | 1 |
| Number of outputchannels and ports(System) | 2 for each | 2 for each | 2 for each | 2 for each |
Table 1: Comparison of Subject vs. Predicate
{5}------------------------------------------------
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 /Microprocessorcontrolled | Yes | Yes | Yes | Yes |
|---|---|---|---|---|
| Voltage / CurrentLevel | 1-10 intensity indicator | 1-10 intensity indicator | 1-10 intensityindicator | 1-10 intensityindicator |
| Timer Range | 8-20 minutes | 8-20 minutes | 8-20 minutes | 8-20 minutes |
| Compliance withvoluntary standards | IEC60601-1IEC 60601-1-2EN 60601-1-6EN 62366EN 60601-1-11 | IEC60601-1IEC 60601-1-2EN 60601-1-6EN 62366EN 60601-1-11 | IEC60601-1IEC 60601-1-2EN 60601-1-6EN 62366EN 60601-1-11 | IEC60601-1IEC 60601-1-2EN 60601-1-6EN 62366EN 60601-1-11 |
| Sterilization | Not provided sterile | Not provided sterile | Not provided sterile | Not provided sterile |
{7}------------------------------------------------
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
{8}------------------------------------------------
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.
§ 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).