MYHEALTHPOINT TELEHEALTH MANAGER
Device Facts
| Record ID | K132930 |
|---|---|
| Device Name | MYHEALTHPOINT TELEHEALTH MANAGER |
| Applicant | Entra Health Systems |
| Product Code | DRG · Cardiovascular |
| Decision Date | Apr 14, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2910 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
The MyHealthPoint Telehealth Manager is an accessory software that wirelessly, collects, records and transmits biometric data (including glucose, blood pressure, weight, body composition, activity, body temperature, ECG and pulse oximeter readings) from a variety of supported home-monitoring devices as well as supporting manual uploading of data. The MyHealthPoint application uses the same data repository platform that is already cleared. MyGlucoHealth Software System (K081703). MyHealthPoint TeleHealth Manager is intended to be used by patients in non-clinical settings (e.g. home) to collect, record and transmit their biometric data to a remote secure server. Stored data is accessible by healthcare professionals and caregivers for analysis, messaging and intervention using standard digital communication technologies and protocols. Patients may also view the data to assist in self-management of their specific health condition. The MyHealthPoint Telehealth Manager is intended to be used in combination with a variety of external vital sign devices. The MyHealthPoint Telehealth Manager is intended to be used by patients identified by their healthcare organization that would benefit from remote monitoring. It is not intended as a replacement of the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring. It does not measure, interpret or make any decisions on the data that it conveys.
Device Story
MyHealthPoint TeleHealth Manager is a software platform (PC/mobile) for remote patient monitoring. It collects biometric data (glucose, BP, weight, activity, temp, ECG, SpO2) from various FDA-cleared external home-monitoring devices via Bluetooth, Wi-Fi, or USB. Data is transmitted to a secure remote server for storage and access by patients, clinicians, and caregivers. The system provides medication reminders, alerts, and graphical reports. It does not interpret data or make clinical decisions; it serves as a conduit for data review and messaging to support chronic disease management and wellness regimens. Used in home settings; operated by patients and monitored by healthcare professionals.
Clinical Evidence
Bench testing only. No clinical data provided. Verification testing confirmed functional specifications, data integrity during collection/transmission/storage, and instructional utility of the user manual.
Technological Characteristics
Software platform for data collection and display. Connectivity via Bluetooth, Wi-Fi, USB, and cellular (via MDDS). Operates on PC or mobile smart devices. Uses standard digital communication protocols. No electrical safety or electromagnetic testing required as it is a software-only application.
Indications for Use
Indicated for patients in non-clinical settings (e.g., home) identified by healthcare organizations as benefiting from remote monitoring of biometric data, including glucose, blood pressure, weight, body composition, activity, body temperature, ECG, and pulse oximetry. Not for real-time or emergency monitoring; not a replacement for professional oversight.
Regulatory Classification
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.
Predicate Devices
- Vignet TeleHealth Manager (K113446)
- Honeywell Genesis DM Monitor (K101242)
- Verizon Wireless Converged Health Management Device (K122458)
Reference Devices
- MyGlucoHealth Software System (K081703)
Submission Summary (Full Text)
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### APR 1 4 2014
Image /page/0/Picture/1 description: The image shows the logo for Entra Health Systems. The logo consists of the letters "E", "h", and "S" arranged horizontally. The "h" is inside of a black circle. Below the letters is the text "Entra Health Systems".
December 26, 2013
| Entra Health Systems LLC | |
|---------------------------|-------------------|
| 3111 Camino del Rio North | |
| | Suite 101 |
| San Diego, CA 92108 | |
| | Main 877 458 2646 |
| | Fax 619 584 4504 |
| | K132930 |
# (in accordance with 21 CFR 807.92)
| A. Submitter: | Entra Health Systems |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Address: | 3111 Camino Del Rio North<br>Suite 101<br>San Diego CA 92108 |
| C. Corporate Contact: | Richard Strobridge, CEO<br>Entra Health Systems |
| D. Telephone: | Ph: 877-458-2646<br>Fax: 619-584-4504 |
| E. Submission Contact: | Emily Davis, Project Manager<br>Entra Health Systems<br>3111 Camino Del Rio North<br>Suite 101<br>San Diego CA 92108<br>Ph: 877-458-2646<br>edavis@entrahealthsystems.com |
| F. Trade Name: | MyHealthPoint TeleHealth Manager |
| G. Predicate Device(s): | - Vignet TeleHealth Manager, K113446<br>- Honeywell Genesis DM Monitor, K101242<br>- Verizon Wireless Converged Health Management Device, K122458 |
| H. Common Name: | Telemedicine System |
- I. Classification:
| Regulation<br>Number | Product<br>Code | Classification Name | Device<br>Class |
|-------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------------------------------------------------------|-----------------|
| 870.2910 | DRG | Radiofrequency Physiological Signal<br>Transmitter and Receiver | II |
| Medical device product codes also supported by MyHealthPoint Telehealth Manager by<br>means of separate medical devices | | | |
| 862.2100 | JQP | Calculator/Data Processing Module | I |
| 870.1130 | DXN | Noninvasive Blood Pressure Measurement | II |
| 870.2700 | DQA | Oximeter | II |
| 880.2910 | FLL | Thermometer, Electronic, Clinical | II |
| 870.2340 | DPS | Elecrocardiograph | II |
| 870.2360 | DRX | Electrocardiograph electrode | II |
| 890.5060 | NXB | Medication Reminder | I |
| 880.2700 | FRI | Patient Weight Scale | I |
| 880.6310 | OUG | Medical device data system | I |
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Image /page/1/Picture/0 description: The image shows the logo for Entra Health Systems. The logo consists of the letters "E", "h", and "S", with the "h" inside of a black circle. Vertical lines separate the letters. The words "Entra Health Systems" are written below the letters in a stylized font.
- J. Device Description
The MyHealthPoint Telehealth Manager is a software platform accessible via PC or mobile smart phone that collects member's biometric data such as activity, blood pressure, blood glucose, ECG, body temperature, body composition/weight and pulse oximetry, and has the ability to send medication reminders. The MyHealthPoint TeleHealth Manager can be used by patients during their daily lives to collect biometric readings from various personal health monitors from a variety of manufacturers to assist in maintaining wellness regimens and the clinical monitoring of patients with chronic disease. The system can be accessed by members, clinicians and caregivers for analysis and intervention using standard digital communication technologies and protocols. The MyHealthPoint Telehealth Manager is intended for use in remote monitoring of patient biometrics and supports messaging between member's, clinicians and caregivers. In addition to monitoring, MyHealthPoint TeleHealth Manager supports reminders, alerts, and online graphical reports to help patients and their healthcare professionals better understand and manage their conditions.
The supported cleared, home-monitoring devices currently marketed with the MyHealthPoint TeleHealth Manager for wireless collection of data and physiological information is in the table below and the systems Architecture is explained on page 3.
| No. | Vital Signs/<br>Product Code | Measurement | Vital Signs Equipment<br>Manufacturers/Models (510k) | Connection Type to<br>MyHealthPoint |
|-----|------------------------------|-------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------|
| 1 | Glucose | Blood glucose (mg/dl or<br>mmol/L) | Entra Health Systems,<br>MGH-BT1, K081703 | Bluetooth through<br>Mobile App, USB or<br>MDDS Device |
| 2 | Weight | Weight Scale ((lbs. or<br>Kgs.)/Body Composition | AnD, UC-321PBT | Bluetooth through<br>MDDS Device |
| | | | Omron, HBF-206IT | Bluetooth through<br>MDDS Device |
| | | | Fora Weight Scale, W310b | Bluetooth through<br>MDDS Device |
| | | | Withings Wi-Fi Scale, WS-50 | Wifi through Home<br>Router |
| 3 | Pulse<br>Oximetry | Pulse Rate and Oxygen<br>Saturation | Nonin, 95608T (K09336) | Bluetooth through<br>MDDS Device |
| 4 | Blood<br>Pressure | Blood pressure (Systolic<br>(mmHg), Diastolic (mmHg)) | AnD,UA-767BTB (K043217) | Bluetooth through<br>MDDS Device |
| | | | Omron BP Monitor, BP792IT<br>(K131742) | Bluetooth through<br>MDDS Device |
| | | | Fora BP Monitor, P20b (K092106) | Bluetooth through<br>MDDS Device |
| 5 | Pedometer | Steps, Calories, Sleep | Fitbit, Flexx, Zip, One, Force | Bluetooth through<br>MDDS Device and<br>USB |
| | | | BodyMedia, Link, Core | Bluetooth through<br>MDDS Device and<br>USB |
| 6 | ECG | Heart Rate, Respiration | Zephyr , Bioharness 3.1 9607.0090<br>(K113045) | Bluetooth through<br>MDDS Device |
| 7 | Thermometer | Body Temperature (Celsius or<br>Fahrenheit) | For a, IR20b (K090395) | Bluetooth through<br>MDDS Device |
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| 8 | Transfer of<br>Data | Medical Device Data System | Qualcomm 2Net,<br>65-KA123 | Receives Bluetooth<br>and sends Cellular |
|---|------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------|
| 9 | Medication<br>Reminder | Member has the optional ability<br>to add medications or products<br>they are using with a reminder<br>sent by SMS or email. | Entra Health Systems | Software<br>component only. |
#### MyHealthPoint TeleHealth System Architecture
Image /page/2/Figure/4 description: The image shows a diagram of a health monitoring system. The system includes wireless devices such as a weight scale, glucose monitor, and blood pressure monitor. These devices connect to interface devices like smartphones, tablets, and computers, which then transmit data to a central data server called the 'MyHealthPoint Platform'. The platform provides APIs for third-party apps and hospital systems, and the data is displayed on mobile devices and clinician portals.
#### K. Intended Use
The MyHealthPoint Telehealth Manager is an accessory software that wirelessly, collects, records and transmits biometric data (including glucose, blood pressure, weight, body composition, activity, body temperature, ECG and pulse oximeter readings) from a variety of supported home-monitoring devices as well as supporting manual uploading of data. The MyHealthPoint application uses the same data repository platform that is already cleared. MyGlucoHealth Software System (K081703).
MyHealthPoint TeleHealth Manager is intended to be used by patients in non-clinical settings (e.g. home) to collect, record and transmit their biometric data to a remote secure server. Stored data is accessible by healthcare professionals and caregivers for analysis, messaging and intervention using standard digital communication technologies and protocols. Patients may also view the data to assist in self-management of their specific health condition. The MyHealthPoint Telehealth Manager is intended to be used in combination with a variety of external vital sign devices.
The MyHealthPoint Telehealth Manager is intended to be used by patients identified by their healthcare organization that would benefit from remote monitoring. It is not intended as a replacement of the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring. It does not measure, interpret or make any decisions on the data that it conveys.
- L. Predicate Devices
The MyHealthPoint Management System is substantially equivalent to the following FDA cleared predicate devices:
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Image /page/3/Picture/0 description: The image shows the logo for Entra Health Systems. The logo consists of the letters "E," "h," and "S" arranged horizontally. The "h" is inside of a black circle. Below the letters is the text "Entra Health Systems".
#### Predicate #1
510(k) Number: Trade Name: Manufacturer: Classification Name:
Common/Usual Name: Regulation Number: Product Codes: Subsequent Product Codes: Classification:
K113446 Vignet TeleHealth Manager Vignet Inc. Radiofrequency Physiological Signal Transmitter and Receiver Telemedicine System 870.2910 DRG DXN, NBW, FRW Class II
#### Predicate #2
K101242 510(k) Number: Trade Name: Genesis DM Monitor Manufacturer: Honeywell HomMed, LLC Radiofrequency Physiological Signal Transmitter Classification Name: and Receiver Common/Usual Name: Patient Vital Signs Monitor 870.2910 Regulation Number: Product Codes: DRG Subsequent Product Codes: DXN, DQA, FRI, NBW, BZH, FLL, GJS, DPS, NXB Classification: Class II
#### Predicate #3
| 510(k) Number: | K122458 |
|---------------------------|-----------------------------------------------------------------|
| Trade Name: | Verizon Wireless Converged Health Management<br>(CHM) Device |
| Manufacturer: | Verizon Wireless |
| Classification Name: | Radiofrequency Physiological Signal Transmitter<br>and Receiver |
| Common/Usual Name: | Telemedicine System |
| Regulation Number: | 870.2910 |
| Product Codes: | DRG |
| Subsequent Product Codes: | DXN, NBW, FRW |
| Classification: | Class II |
Entra Health systems has determined that the MyHealthPoint TeleHealth Manager is substantially equivalent to the performance of the three mention predicate devices. The differences between these systems are incidental and not significant. The devices use a similar technological characteristics and principles. Substantial Equivalence section in this submission (Tab 11) explains more on the similarities and equivalence.
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#### M. Technological Characteristics
The MyHealthPoint TeleHealth Manager is a software platform for the collection and display of biometric data, from primarily supported patient monitoring devices, to the patient, caregiver and clinician. It is used with in combination with a variety of FDA cleared external bio-metric measuring devices included in the table that follows. Technological characteristics of our device compared to each predicate is shown on the following tables and in the Substantial Equivalence (Tab 11).
#### M1.DEVICES
| Vital Signs/<br>Product Code | Measurement of<br>Submitted Device<br>(MyHealthPoint) | Vital Signs Equipment<br>Manufacturers/Models<br>(510k) | Predicate #1<br>Vignet Inc. | Predicate #2<br>Honeywell<br>HomMed | Predicate #3<br>Verizon<br>Wireless |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------|-------------------------------------|------------------------------------------|
| Glucose<br>(NBW) | Blood glucose<br>(mg/dl or mmol/L) | Entra Health Systems,<br>MGH-BT1, K081703<br><br>AnD, UC-321PBT | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially<br>Equivalent |
| Weight (FRI) | Weight Scale (lbs.<br>or Kgs.)/<br>Body Composition | Omron, HBF-206IT<br>Fora Weight Scale,<br>W310b<br>Withings Wi-Fi Scale,<br>WS-50 | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially<br>Equivalent |
| Pulse<br>Oximetry<br>(DQA) | Pulse Rate and<br>Oxygen Saturation | Nonin, 9560BT, K09336 | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially<br>Equivalent |
| Blood<br>Pressure<br>(DXN) | Blood pressure<br>((Systolic (mmHg),<br>Diastolic (mmHg)) | AnD, UA-767PBT,<br>K043217<br>Omron BP Monitor,<br>BP792IT, K131742<br>Fora BP Monitor, P20b,<br>K092106 | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially<br>Equivalent |
| Pedometer<br>(Activity) | Steps, Calories,<br>Sleep | Fitbit, Flexx, Zip, One,<br>Force<br>BodyMedia, Link, Core | Substantially<br>Equivalent | Does not track<br>activity. | Does not track<br>activity. |
| ECG (DSI,DRX,<br>DPS) | Heart Rate,<br>Respiration | Zephyr , Bioharness 3.1<br>9607.0090, K113045 | Does not have<br>ECG | Substantially<br>Equivalent | Does not have<br>ECG |
| Thermometer<br>(FLL) | Body Temperature<br>(Celsius or<br>Fahrenheit) | For a, IR20b, K090395 | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially<br>Equivalent |
| Transfer of<br>Data (OUG) | Medical Device Data<br>System | Qualcomm 2Net,<br>65-KA123 | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially<br>Equivalent |
| Medication<br>Reminder<br>(NXB) | Member has the<br>optional ability to<br>add medications or<br>products they are<br>using with a<br>reminder sent by | Built into<br>MyHealthPoint by Entra<br>Health Systems. | Does not have<br>medication<br>reminder. | Substantially<br>Equivalent | Does not have<br>medication<br>reminder. |
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#### M2.FEATURES
| Feature | Submitted Device<br>(My Health Point) | Predicate #1<br>Vignet Inc. | Predicate #2<br>Honeywell<br>HomMed | Predicate #3<br>Verizon Wireless |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------------------------|----------------------------------|
| Intended Use | Home use, wireless<br>collection of data;<br>Remote data access | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially Equivalent |
| Indication for<br>Use (Ref: Tab 4) | Remote health<br>management | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially Equivalent |
| System<br>description | Software, wireless,<br>reporting and charts,<br>messaging, targets and<br>alerts | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially Equivalent |
| Feature | Submitted Device<br>(MyHealthPoint) | Predicate #1<br>Vignet Inc. | Predicate #2<br>Honeywell<br>HomMed | Predicate #3<br>Verizon Wireless |
| Data Collection<br>software | Proprietary Software | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially Equivalent |
| Types of home<br>use devices<br>interfaced | FDA cleared home<br>devices: Glucose, Blood<br>pressure, weight/body<br>composition, pulse<br>oximeter, thermometer,<br>ECG, activity, medication<br>reminder | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially Equivalent |
| Data Capture<br>method<br>(connectivity) | Wireless, cellular, server<br>to server, client to<br>server. | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially Equivalent |
| Power source | Smart device battery,<br>plug for MDDS | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially Equivalent |
| Display | Computer, smart phone | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially Equivalent |
| Messaging | Secure messages, SMS<br>messaging, motivational,<br>reminders, on line<br>graphical reports and<br>charts, personal<br>progress indicators | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially Equivalent |
| Configuration of<br>personal<br>wellness regimen | Configures patient alert<br>settings set by clinician.<br>Messaging. | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially Equivalent |
N. Performance (non-clinical) data
The MyHealthPoint TeleHealth Manager is a software application, therefore no electrical safety or electromagnetic testing was required. After extensive bench testing to performance requirements and criteria established in accordance with application of EN14971 risk analysis,
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Image /page/6/Picture/0 description: The image shows the logo for Entra Health Systems. The logo consists of the letters "E", "h", and "S" arranged horizontally. The "h" is inside a black circle, and the letters are separated by vertical lines. Below the letters, the words "Entra Health Systems" are written in a stylized font.
no new issues of safety, performance, technology or intended use were identified. Testing conducted to demonstrate software validation and substantial equivalence included:
- . Verification testing that product meets product performance and functional specifications.
- . Verification that biometric data submitted by personal home-use devices are captured (wirelessly or manually), transmitted and stored properly to maintain data integrity (e.g. no loss of data or corruption)
- User performance testing to demonstrate adequate instructional utility of the User . Manual.
Therefore the MyHealthPoint TeleHealth Manager is concluded to be substantially equivalent to the identified predicates.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2014
Entra Health Systems Richard Strobridge 3111 Camino Del Rio North Suite 101 San Diego, CA 92108 US
Re: K132930
> Trade/Device Name: MyHealthPoint TeleHealth Manager Regulation Number: 21 CFR 870.2910 Regulation Name: Telemedicine System Regulatory Class: Class II Product Code: DRG, JQP, DXN, DQA, FLL, DPS, DRX, NXB, FRI, OUG Dated: March 15, 2014 Received: March 21, 2014
Dear Richard Strobridge:
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. 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
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Page 2 - Richard Strobridge
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree free number 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known):
Device Name: MyHealthPoint Telehealth Manager
Indications for Use
The MyHealthPoint Telehealth Manager is an accessory software that wirelessly collects, records and transmits biometric data (including glucose, blood pressure, weight, body composition, activity, body temperature, ECG and pulse oximeter readings) from a variety of supported home-monitoring devices as well as supporting manual uploading of data. The MyHealthPoint application uses the same data repository platform that is already cleared, MyGlucoHealth Software System (K081703).
MyHealthPoint TeleHealth Manager is intended to be used by patients in non-clinical settings (e.g. home) to collect, record and transmit their biometric data to a remote secure server. Stored data is accessible by healthcare professionals and caregivers for analysis, messaging and intervention using standard digital communication technologies and protocols. Patients may also view the data to assist in self-management of their specific health condition. The MyHealthPoint Telehealth Manager is intended to be used in combination with a variety of external vital sign devices.
The MyHealthPoint Telehealth Manager is intended to be used by patients identified by their healthcare organization that would benefit from remote monitoring. It is not intended as a replacement of the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring. It does not measure, interpret or make any decisions on the data that it conveys.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/9/Picture/14 description: The image shows a logo with the letters FDA and the word Date. The date is 2014.04.08:59-04'00'. The logo is in black and white.
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