(308 days)
Not Found
No
The document describes standard ECG signal processing for heart rate calculation and display, without mentioning any AI or ML techniques for analysis or control.
Yes
The device is described as a rehabilitation system used to control the training load for a patient's rehabilitation or preventive training activities, aligning with the definition of a therapeutic device.
No
The "Intended Use / Indications for Use" section explicitly states: "The ers2 system is not intended to be used to detect or diagnose cardiac conditions (e.g. arrhythmias, ST-elevation, etc. pp)." While it records ECG data, its purpose is for heart rate calculation, visual QRS assessment, and controlling training load during rehabilitation, not for diagnostic purposes.
No
The device description explicitly states that the system consists of both software (ers2) and hardware (ers2 1CH ECG Telemetry system), including a transmitter, adapter, and receiver.
Based on the provided information, the ers2 – ergoline Rehabilitation System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- ers2 Function: The ers2 system acquires a surface ECG signal directly from the patient's intact skin using electrodes. It processes this signal for heart rate calculation, visual assessment of the QRS complex, and to control training load.
- Intended Use: The intended use explicitly states that the system is not intended to be used to detect or diagnose cardiac conditions. Its purpose is for monitoring and controlling training activities during rehabilitation or preventive training.
- No Specimen Analysis: The system does not analyze any specimens taken from the body.
Therefore, the ers2 system falls under the category of a medical device that monitors physiological parameters directly from the patient's body, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ers2 – ergoline Rehabilitation System is a device for recording of a single-channel, bipolar surface ECG (frontal plane) acquired with two ECG electrodes. The ECG is transmitted to the ers2 software where it is processed for heartrate calculation, displayed for visual QRS complex assessment and to control the training load for a patient´s rehabilitation or preventive training activities.
The ers2 system is not intended to be used to detect or diagnose cardiac conditions (e.g. arrhythmias, ST-elevation, etc. pp).
The signal is acquired on the intact skin of adult patients.
The medical device is intended for use in professional healthcare Institutions for inpatient and outpatient care.
Product codes (comma separated list FDA assigned to the subject device)
DRG
Device Description
The Ergoline Rehabilitation System 2 consists of a) software (ers2) and b) hardware (ers2 1CH ECG Telemetry system).
a) The software system runs on a PC and is used by therapists to monitor, control and document the training sessions of rehabilitation patients (e.g. in endurance and strength training), whereby the patient can train on different devices or free without the support of devices. Free training can, for example, be performed on strength training equipment or through gymnastic exercises.
The central component of the ers2 system is a PC with an MS Windows operating system and special software which runs the training programs. The training ergometers are connected to the PC system via control lines or a WiFi interface. All data are shown on one to three 22-inch TFT monitors; up to eight patients can be displayed and supervised on each monitor. The ers2 software receives the patient's physiological parameters from the ers2 1CH ECG Telemetry System and uses them for display on the monitor as well as to control the training devices.
Data are transferred between the wireless ergoline ECG transmitter and PC via Bluetooth©.
b) Via the applied part, the ers2 1CH ECG Transmitter acquires a single-channel, bipolar raw ECG signal and sends it to a medical application software or other ME equipment by radio transmission.
The ers2 1CH ECG transmitter is an ME device powered from integrated, exchangeable, rechargeable batteries
These are the components of the ers2 1CH ECG Telemetry system:
. ers2 1CH ECG Transmitter consisting of enclosure, ECG amplifier, radio transmission module, micro-controller with firmware and device connection of the ECG adapter, is worn on the body near the heart and affixed to the ETS1 adapter no skin contact, accessible part, type CF.
. The ers2 1CH ECG adapter (applied part, ECG patient connection) with device socket for connection to the ECG transmitter and device socket for connection to the patient connection (ECG electrode), is worn on the body near the heart, type CF.
. ers2 ECG receiver, receives the ECG signals transmitted by radio. Permanently connected to USB port of a Windows PC. Operated outside patient environment, accessible part, protection class II.
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
adult patients
Intended User / Care Setting
Professional user in a clinical setting in professional healthcare Institutions for inpatient and outpatient care.
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)
Electrical Safety and Electromagnetic Compatibility testing: ers2 - ergoline Rehabilitation System was tested according to and is in compliance with recognized standards for electrical safety and electromagnetic compatibility.
Software and System validation: The ers2 - ergoline Rehabilitation System comprises "ETS1 Transmitter firmware" and the software "ers2 software" which were verified and validated according to IEC 62304. Software validation demonstrated that the "ETS1 Transmitter firmware" and "ers2 software" met the software system requirements.
Usability validation: The overall system was validated to confirm that the device meets its intended use, i.e. can be used as intended by the specified users within the specified use environment, taking into account human factors and usability requirements.
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
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 15, 2022
ergoline GmbH Alexandra Lertz Quality Manager Lindenstrasse 5 Bitz, Hessen 72475 Germany
Re: K212883
Trade/Device Name: ers2 - ergoline Rehabilitation System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II Product Code: DRG Dated: Mav 30, 2022 Received: June 3, 2022
Dear Alexandra Lertz:
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 statutes and regulations administered by other Federal agencies.
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-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 mediation-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,
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212883
Device Name
ers2 - ergoline Rehabilitation System
The ers2 – ergoline Rehabilitation System is a device for recording of a single-channel, bipolar surface ECG (frontal plane) acquired with two ECG electrodes. The ECG is transmitted to the ers2 software where it is processed for heartrate calculation, displayed for visual QRS complex assessment and to control the training load for a patient's rehabilitation or preventive training activities.
The ers2 system is not intended to be used to detect or diagnose cardiac conditions (e.g. arrhythmias, ST-elevation, etc. pp).
The signal is acquired on the intact skin of adult patients.
The medical device is intended for use in professional healthcare for inpatient and outpatient care.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary for ers2 - ergoline Rehabilitation System
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirement of 21 CFR 807.92
Sponsor
- Sponsor: ergoline GmbH Lindenstrasse 5 72475 Bitz Germany
- Contact Person: Mr. Andreas Maurer amaurer@ergoline.com +49 7431 9894 138
- May 31, 2022 Date Prepared:
510(k) number: K212883
Device Name and Classification
- Proprietary Name: ers2 - ergoline Rehabilitation System
Common/Usual Name: Transmitters and receivers, physiological signal, radiofrequency
Classification Name: Cardiovascular Monitoring Devices (21 CFR 870.2910, Product Code DRG)
Predicate Device
TeleRehab 2004 Cardiopulmonary Rehabilitation System, K050778 Predicate Device:
Intended Use
The ers2 – ergoline Rehabilitation System is a device for recording of a single-channel, bipolar surface ECG (frontal plane) acquired with two ECG electrodes. The ECG is transmitted to the ers2 software where it is processed for heartrate calculation, displayed for visual QRS complex assessment and to control the training load for a patient´s rehabilitation or preventive training activities.
The ers2 system is not intended to be used to detect or diagnose cardiac conditions (e.g. arrhythmias, ST-elevation, etc. pp).
The signal is acquired on the intact skin of adult patients.
The medical device is intended for use in professional healthcare Institutions for inpatient and outpatient care.
4
Device Description and Function
The Ergoline Rehabilitation System 2 consists of a) software (ers2) and b) hardware (ers2 1CH ECG Telemetry system).
- a) The software system runs on a PC and is used by therapists to monitor, control and document the training sessions of rehabilitation patients (e.g. in endurance and strength training), whereby the patient can train on different devices or free without the support of devices. Free training can, for example, be performed on strength training equipment or through gymnastic exercises.
The central component of the ers2 system is a PC with an MS Windows operating system and special software which runs the training programs. The training ergometers are connected to the PC system via control lines or a WiFi interface. All data are shown on one to three 22-inch TFT monitors; up to eight patients can be displayed and supervised on each monitor. The ers2 software receives the patient's physiological parameters from the ers2 1CH ECG Telemetry System and uses them for display on the monitor as well as to control the training devices.
Data are transferred between the wireless ergoline ECG transmitter and PC via Bluetooth©.
- b) Via the applied part, the ers2 1CH ECG Transmitter acquires a single-channel, bipolar raw ECG signal and sends it to a medical application software or other ME equipment by radio transmission.
The ers2 1CH ECG transmitter is an ME device powered from integrated, exchangeable, rechargeable batteries
These are the components of the ers2 1CH ECG Telemetry system:
- . ers2 1CH ECG Transmitter consisting of enclosure, ECG amplifier, radio transmission module, micro-controller with firmware and device connection of the ECG adapter, is worn on the body near the heart and affixed to the ETS1 adapter no skin contact, accessible part, type CF.
- . The ers2 1CH ECG adapter (applied part, ECG patient connection) with device socket for connection to the ECG transmitter and device socket for connection to the patient connection (ECG electrode), is worn on the body near the heart, type CF.
- . ers2 ECG receiver, receives the ECG signals transmitted by radio. Permanently connected to USB port of a Windows PC. Operated outside patient environment, accessible part, protection class II.
Predicate Device Comparison
General
Table 1: Basic Device Characteristics – Comparison with Predicate Device
| Characteristic | New Device | Primary predicate
device | Similar / Different |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K212883 | K050778 | - |
| Device Name, Model | | | |
| | ers2 - ergoline
Rehabilitation System | TeleRehab 2004
Cardiopulmonary
Rehabilitation System | - |
| Manufacturer | ergoline GmbH | ScottCare | - |
| Regulation Number | 890.2910 | 890.2910 | Similar |
| Product code | DRG | DRG | Similar |
| Indications for Use | The ers2 – ergoline
Rehabilitation System
is a device for
recording of a single-
channel, bipolar
surface ECG (frontal
plane) acquired with
two ECG electrodes.
The ECG is
transmitted to the
ers2 software where it
is processed for
heartrate calculation,
displayed for visual
QRS complex
assessment and to
control the training
load for a patient´s
rehabilitation or
preventive training
activities.
The ers2 system is not
intended to be used
to detect or diagnose
cardiac conditions
(e.g. arrhythmias, ST-
elevation, etc. pp).
The signal is acquired
on the intact skin of
adult patients.
The medical device is
intended for use in
professional
healthcare Institutions
for inpatient and
outpatient care. | This device is intended
to acquire and
condition the ECG
signal from a patient
so that it can be
transmitted via radio
frequency (WMTF)
with a Stickman
telemetry transmitter
to a workstation in a
hospital or clinical
setting where the ECG
is displayed and
analyzed. This device
is for use with
ambulatory adult
patients, which need
monitoring while
undergoing cardiac or
pulmonary
rehabilitation. The
data output from
monitoring is viewed
and stored on a
workstation for
tracking of the
patients' progress
through rehabilitation.
Patient demographics,
exercise protocol and
medical information
can be entered via a
variety of
commercially available
wireless input devices
or automatically
through an HL-7
hospital network
interface. A database
can be created for use
with an Outcomes
program. | Similar besides
different frequency
bands and a different
proprietary protocol
to encode the
transmitted data |
| Transmission signal | Radiofrequency | Radiofrequency | Similar |
| Transmission
equipment | Telemetry transmitter
and receiver | Telemetry transmitter
and receiver | Similar |
| Frequency band | 2402 – 2483,5 MHz | 608-614MHz | Different |
| Frequency response | 0.05 – 125 Hz | 0.05 – 100 Hz | Similar |
| Dynamic Range | ± 6 mV | ± 5 mV | Similar |
| Rejection Ratio | > 80 dB | 80 dB | Similar |
| Type | CF, defibrillation
protected | CF, defibrillation
protected | Similar |
| Defibrillation
Recovery | Within 5 seconds | Within 8 seconds | Similar |
| Maximum distance | 164 feet | 100 feet | Different |
| Displayed parameters | ECG, HR, Thr; Load
and RPM, Slope and
speed, BP, CAL, METS | ECG, HR, SpO2, BP,
THR, CAL, METS,
RHR, RBP | Similar for the
intended use |
| Connection of the
device to electrodes | Electrodes are
connected via cables
to the adapter and
thus to the
transmitter. | Electrodes are
connected via cables
directly to the
transmitter | Different |
| Electrodes | 2 standard 510(k)
cleared sticking
electrodes | 3 or 5 standard 510(k)
cleared sticking
electrodes | Similar |
| Power Source(s) | Transmitter: 1 x
HR03/AAA NiMH
rechargeable battery,
1.2 V | Transmitter: 3x AAA,
alkaline batteries, 1.5
V | Different |
| Battery life | 6 hours, rechargeable | 60 hours | Different |
| - Method of Line
Current Isolation | Power Supply in
accordance with IEC
60601-1 | Power Supply in
accordance with IEC
60601-1 | Similar |
| Operator | Professional user in a
clinical setting | Professional user in a
clinical setting | Similar |
| Compliance with 21
CFR 898?
(Mandatory since
May 9, 2000) | Yes | Yes | Similar |
| Lead wires – cables | M-PUR: Compliant
with protected lead
wire and patient cable
safety requirements | DIN: Compliant with
protected lead wire
and patient cable
safety requirements | Different |
| Patient contact
material | Cord:
Silicone, ELASTOSIL® R
Plus 4001/60 MH
(WACKER) | Cord:
DIN style shielded lead
wire
ECG leadwires with
electrode clips: | Different |
5
6
7
| | electrode clips:
M-PUR
Electrodes:
Standard 510(k)
cleared sticking
electrodes, not
included with the
device
Adapter base:
TPE, THERMOLAST® M
TM9MED (TPE
Kraiburg)
Colorant: Masterbatch
Blau (Pantone 7451 U)
Transmitter:
SINKRAL L 322 - ABS | M-PUR
Electrodes:
Standard 510(k)
cleared sticking
electrodes, not
included with the
device
Transmitter:
Polymer | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Environmental
conditions: | Temperature:
-20 – 65 °C
Relative Humidity:
10 – 95 % | Temperature:
10 – 40 °C
Relative Humidity:
10 – 90 % | Similar |
| Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-27
ANSI/AAMI EC53
EN 61000-4-2
EN 61000-4-3
EN 61000-4-6
EN 61000-4-8
EN 55011
EN 55032
ISO 14971
IEC 62366-1
IEC 62304
ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-12 | IEC 60601-1
IEC 60601-1-2
ANSI/AAMI EC-13
EN 61000-3-2
EN 61000-3-3
EN 61000-4-2
EN 61000-4-3
EN 61000-4-4
EN 61000-4-5
EN 61000-4-6
EN 61000-4-8
EN 55011 | Similar |
8
Performance Testing
Electrical Safety and Electromagnetic Compatibility testing: ers2 - ergoline Rehabilitation System was tested according to and is in compliance with recognized standards for electrical safety and electromagnetic compatibility.
Software and System validation: The ers2 - ergoline Rehabilitation System comprises "ETS1 Transmitter firmware" and the software "ers2 software" which were verified and validated according to IEC 62304. Software validation demonstrated that the "ETS1 Transmitter firmware" and "ers2 software" met the software system requirements.
Usability validation: The overall system was validated to confirm that the device meets its intended use, i.e. can be used as intended by the specified users within the specified use environment, taking into account human factors and usability requirements.
Performance Standards
The ers2 - ergoline Rehabilitation System complies with the applicable requirements of the following international and national standards:
- . IEC 60601-1:2005 + A1:2012 - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- IEC 60601-1-2:2014 - Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
- . IEC 60601-2-27:2011 + COR1:2012 - Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
- IEC 62304:2006 + A1:2015 - Medical Device Software - Software Life Cycle Processes
- o ISO 14971:2019 - Medical Devices - Application Of Risk Management To Medical Devices
- IEC 62366-1:2015 + COR1:2016 - Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices
- ISO 10993-1:2018 - Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process
- . ISO 10993-5:2009 - Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10:2010 - Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- . ISO 10993-12:2012 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- ISO 10993-18:2020: Biological evaluation of medical devices – Part 18: Chemical characterization of materials
9
- 0 ANSI AAMI EC53:2013/(R)2020 - ECG trunk cables and patient leadwires
- EN 55011:2011 - Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
- EN 55032:2016 - Electromagnetic compatibility of multimedia equipment - Emission Requirements
- . ISO 15223-1: 2016: Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements
- . ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
The following FDA Guidance Documents have been applied:
- . FDA: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 2005
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 2014
- Off-The-Shelf Software Use in Medical Devices, 2019
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", 2020
- o Radio Frequency Wireless Technology in Medical Devices, 2013
- Applying Human Factors and Usability Engineering to Medical Devices, 2016
- Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, 2017
- . Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, 2015
Conclusion
Both the subject and the predicate device have a similar intended use and use comparable technical features. They both fulfill the same applicable standards for Medical Electrical Equipment. However, the devices differ in terms of a different frequency band and a different protocol to encode the transmitted data as well as different patient superficial contacting material. Fulfilling all applicable FDA-recognized consensus standards for Radio Frequency Wireless Technology, Electromagnetic Compatibility and Biocompatibility, no further questions regarding safety and performance are raised. Both devices are deemed to be substantially equivalent.