Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub

Q: Who is the manufacturer of Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub?

Current Health , Ltd. filed the 510(k) submission for Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub (K190073).

Q: What is the FDA product code for Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub?

MSX. It is classified under 21 CFR 870.2300 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub?

snap40 Wearable Vital Signs Monitoring System (K182543); VitalConnect Platform (K141167); IACS (K113798).

Q: Who can help prepare an FDA 510(k) submission like Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K190073 · Current Health , Ltd. · MSX · Mar 27, 2019 · Cardiovascular

Device Facts

Record ID	K190073
Device Name	Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub
Applicant	Current Health , Ltd.
Product Code	MSX · Cardiovascular
Decision Date	Mar 27, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2300
Device Class	Class 2

Intended Use

The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated. The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults: Pulse rate, Oxygen saturation, Temperature, Movement. The Current Wearable Health Monitoring System is intermittent or spot-check monitoring of respiration rate, non-invasive blood pressure and weight in adults. The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms. The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor. The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

Device Story

Wearable upper-arm device; monitors pulse rate, SpO2, temperature, movement; integrates with external blood pressure and weight devices. Data transmitted to software platform/central station for professional healthcare review. Used in hospitals, skilled nursing, or home; patient applies device/charges; healthcare professionals monitor remotely or on-site. Provides visual/audible alarms. Aids clinical decision-making by providing physiologic data; benefits include continuous monitoring outside high-acuity settings.

Clinical Evidence

No clinical studies conducted. Evidence based on bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), alarm system verification (IEC 60601-1-8), pulse rate and SpO2 accuracy (ISO 80601-2-61), respiratory rate accuracy, temperature accuracy (ISO 80601-2-56), wireless coexistence, and usability (IEC 62366).

Technological Characteristics

Upper-arm wearable device; wireless radio communication; QI charging; battery-powered. Biocompatible materials (ISO 10993-1). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 80601-2-61, ISO 80601-2-56, IEC 62366, ASTM D4169. Software-based alarm system and data platform.

Indications for Use

Indicated for adult patients in professional healthcare facilities (hospitals, skilled nursing) or home settings for continuous monitoring of pulse rate, SpO2, temperature, and movement, and intermittent monitoring of respiration rate, non-invasive blood pressure, and weight. Contraindicated for high-acuity environments (ICU, OR) and acutely ill cardiac patients prone to life-threatening arrhythmias (e.g., fast atrial fibrillation). Not for SpO2 monitoring during high motion or low perfusion.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

snap40 Wearable Vital Signs Monitoring System (K182543)
VitalConnect Platform (K141167)
IACS (K113798)

Related Devices

K210133 — Current Health Monitoring System Gen 2 (G2) · Current Health · Sep 3, 2021
K191272 — Wearable Device, Wearable Package · Current Health , Ltd. · Jul 12, 2019
K182543 — Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package · Snap40, Ltd. · Nov 14, 2018
K233418 — Biofourmis Everion+ (G2) · Biofourmis Singapore Pte., Ltd. · May 9, 2024
K231506 — Current Health System · Current Health , Ltd. · Aug 24, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. March 27, 2019 Current Health Ltd. Edwin Lindsay OA/RA Manager Playfair House. 12A Broughton Street Lane Edinburgh, EH1 3LY Gb Re: K190073 Trade/Device Name: Current Wearable Health Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX, DQA, FLL, BZQ, DRG Dated: January 11, 2019 Received: January 16, 2019 Dear Edwin Lindsay: 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. 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 {1}------------------------------------------------ 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, ## Jessica E. Paulsen -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K190073 #### Device Name Current Wearable Health Monitoring System #### Indications for Use (Describe) The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring temperature at the upper arm is clinically indicated. The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults: - · Pulse rate - · Oxygen saturation - · Temperature - Movement The Current Wearable Health Monitoring System is intermittent or spot-check monitoring of respiration rate, non-invasive blood pressure and weight in adults. The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms. The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmas e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor. The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion. 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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 Druq 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." {4}------------------------------------------------ For Current Wearable Health Monitoring System ### 510(k) Summary This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92. ### Submitter's Name: Current Health Ltd ### Submitter's Address: Playfair House, 12A Broughton Street Lane Edinburgh EH1 3LY Telephone: +44 (0) 131 560 1137 ### Establishment Registration Number: Still to be established ### Contact Person: Edwin Lindsay Telephone +44 (0) 7917134922 ### Date Prepared: 11th January 2019 Note: snap40 Ltd has recently changed their name to Current Health Ltd. {5}------------------------------------------------ For Current Wearable Health Monitoring System ### Below summaries the Device Classification Information regarding the Current Wearable Health Monitoring System: ### Primary Product Code: | Regulation Number | Device | Device Class | Product Code | Classification Panel | |----------------------|-----------------------------------------------------------------|-----------------|-----------------|-------------------------| | 870.2300 | System, Network and Communication, Physiological Monitors | Class 2 | MSX | Cardiovascular | ### Secondary Product Codes: | Regulation Number | Device | Device Class | Product Code | Classification Panel | |----------------------|------------------------------------------------------------------------|-----------------|-----------------|-------------------------| | 880.2910 | Thermometer, Electronic, Clinical | Class 2 | FLL | General Hospital | | 870.2700 | Oximeter | Class 2 | DQA | Cardiovascular | | 868.2375 | Monitor, Breathing Frequency | Class 2 | BZQ | Anesthesiology | | 870.2910 | Transmitters and Receivers, Physiological Signal, Radiofrequency | Class 2 | DRG | Cardiovascular | #### Device Trade Name: Current Wearable Health Monitoring System ### Device Common Name: Current Wearable Health Monitoring System ### Intended/ Indications Use: The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated. The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults: - Pulse rate - . Oxygen saturation - Temperature - Movement ● {6}------------------------------------------------ For Current Wearable Health Monitoring System The Current Wearable Health Monitoring System is intermittent or spot-check monitoring of respiration rate, non-invasive blood pressure and weight in adults. The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms. The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.q. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor. The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion. {7}------------------------------------------------ For Current Wearable Health Monitoring System ### Summary of Substantial Equivalence: The following predicate devices have been that the Current Wearable Heath Monitoring System can claim equivalence with and these are detailed below ### General Comparison | Property | Proposed Device Current Wearable Health Monitoring System | Primary Predicate snap40 Wearable Vital Signs Monitoring System | Secondary Predicate: VitalConnect Platform | Secondary Predicate: IACS | Comment | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name | System, Network and Communication, Physiological Monitors | System, Network and Communication, Physiological Monitors | Transmitters and Receivers, Physiological Signal, Radiofrequency | Monitor, Physiological, Patient (With Arrhytmia Detection or Alarms) | N/A | | Device Manufacturer | Current Health Ltd | Current Health Ltd | Philips | Draeger | N/A | | Device Classification | II | II | II | II | N/A | | 510(k) Number | N/A | K182543 | K141167 | K113798 | N/A | | Primary Product Code | MSX | MSX | DRG | MHX | N/A | | Secondary Product Code | FLL DQA BZQ DRG | FLL DQA BZQ DRG | DSI MHX | MSX, DRT, DQA, BZQ, FLL, DSK, FLS, MLD, DXN, CCK | N/A | | Target Population | Adult | Adult | Adult | Adult, Paediatric and Neonatal | The proposed device and predicates are identical | | Environment | Professional Healthcare Facilities & home | Hospital | Professional Healthcare Facilities & Home | Hospital | The proposed device and secondary predicate are identical | | Property | Proposed Device Current Wearable Health Monitoring System | Primary Predicate snap40 Wearable Vital Signs Monitoring System | Secondary Predicate: VitalConnect Platform | Secondary Predicate: IACS | Comment | | Intended Use/ Indication for Use | The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi- parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. | snap40 is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in environments where patient care is provided by trained healthcare professionals. snap40 is intended to provide visual and audible physiologic multi-parameter alarms. Snap40 is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated. Snap40 is intended for continuous monitoring of the following parameters in adults: Pulse rate Oxygen saturation Temperature Movement snap40 is intended for intermittent or spot- check monitoring of respiration rate in adults. | The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes heart rate, electrocardiography (EGG), heart rate variability (R-R interval), respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data is transmitted wirelessly to a central location where it is stored for analysis. The Vital Connect Platform can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform is intended for use by healthcare | The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. The IACS obtains the physiologic, multi- parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The Infinity M540 is intended for the monitoring of multi- parameter, physiological patient information obtained from connected hardware in environments where patient care is provided by trained healthcare professional. The M540 is intended to monitor one patient at a time. The M540 monitors the following parameters. | The intended use and indications for use of the proposed device and the predicates are the same except that the primary predicate is only intended for use in the hospital. The intended use and indications for use of the proposed device and the secondary predicate, the Vital Connect, are the same in that they both offer multi-parameter physiologic monitoring in healthcare setting and in the home. The intended use and indications for use of the proposed device and the secondary predicate, the Draeger IACS, are the same in that they both monitor blood pressure non-invasively. | | Property | Proposed Device Current Wearable Health Monitoring System | Primary Predicate snap40 Wearable Vital Signs Monitoring System | Secondary Predicate: VitalConnect Platform | Secondary Predicate: IACS | Comment | | | The Current Wearable Health Monitoring System is intended for intermittent or spot- check monitoring of respiration rate, non- invasive blood pressure and weight in adults. | Snap40 is not intended for use in high-acuity environments, such as ICU or operating rooms or for use in the home | professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients. | · Heart rate · Arrhythmia (adult and pediatric only) · 12-lead analysis · ST segment analysis including TruST® (adult and pediatric only) · 12-lead ST segment analysis (adult and pediatric only) · Apnea · Respiration rate · Invasive pressure · Non-invasive pressure · Temperature · Cardiac output (only available when the M540 is docked in an IACS configuration) · Arterial oxygen saturation (SpO 2) · Pulse rate · Perfusion Index (P1) · Total hemoglobin (SpHb) - adult and pediatric only · Total oxygen content (SpCO) - adult and pediatric only · Methemoglobin saturation (SpMet) · Pleth variability index (PVI) · Mainstream etCO2 | | | | The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms. | snap40 is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. Snap40 is not a substitute for an ECG monitor. | | | | | | The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor. | Snap40 is not intended for SpO2 monitoring in conditions of high motion or low perfusion | | | | {8}------------------------------------------------ For Current Wearable Health Monitoring System Page 5 of 10 K190073 {9}------------------------------------------------ For Current Wearable Health Monitoring System Any technical differences have been justifically and using performance testing. These do not affect the safety or effectiveness of the proposed device. {10}------------------------------------------------ For Current Wearable Health Monitoring System ### Device Description: The Current Wearable Health Monitoring System consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station. The Current Wearable Health Monitoring System is also integrated with specific devices for monitoring of blood pressure and weight. The system is intended to continuously monitor adult patient vital signs in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. It is intended to continuously monitor pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). Current is intended for intermittent or spot-checking monitoring of respiration rate (RESP), blood pressure (BP) and weight (WEIGHT). In the home environment, the patient will have responsibility for applying the device to their arm, charging the device and plugging in the Homehub to mains power. However, the data will still be made directly available to healthcare professionals. These healthcare professionals will be at a remote location e.q. an office or within the hospital or could be with the patient in their own home. ### Technological Characteristics: A comparative review of the Current Wearable Health Monitoring System with the predicate device found that the technology, mode of operation, and general principles for treatment with this device were substantially equivalent.as the predicate device. ### Non-Clinical Tests (Performance/Physical Data): The Current Wearable Health Monitoring System was evaluated for its safety and effectiveness based on the following testing: | Test Name | Test Description | Results | |---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Electrical Safety | The Current Health System was tested to confirm that it met the applicable standards for electrical safety (IEC 60601-1) | Passed | | EMC | The Current Health System was tested to confirm that it met the applicable standards for electromagnetic compatibility (EMC) (IEC 60601-1- 2) | Passed | | QI Charger Testing | The Current Health Wearable was tested to confirm the device could be charged using the QI Charger | Passed | | Environment Testing | The Current Health System was tested to confirm the storage and operating temperature ranges. | Passed | | Test Name | Test Description | Results | | Alarm Testing | The Current Health System was tested to confirm that it met the applicable standards for basic safety and essential performance for alarm systems (IEC 60601-1-8) Alarm Function Verification Tests for each parameter function were performed. | Passed | | Pulse Rate Testing Validation of the accuracy of pulse rate monitoring | The Current Health System was tested to confirm the accuracy of pulse rate monitoring of the system in accordance with ISO 80601-2-61 and the FDA Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and FDA Staff. 2007 | Passed | | Battery Testing | The Current Health Wearable Device Battery Life testing was performed to determine the battery life of the Wearable Device while operating in various modes as well as time to fully charge. | Passed | | PDU Buffering Time Testing | The Current Health system was tested to evaluate the difference between the theoretical maximum PDU buffering time and the observed maximum PDU buffering time. | Passed | | Usability Testing | The Current Health System was assessed with regards to usability for compliance with IEC 62366 - Medical devices - Application of usability engineering to medical devices and IEC 60601-1-11 | Passed | | Device Ship/Transport Testing | Ensure device, enclosed in the selected shipping container, meets ASTM D4169 specifications. | Passed | | Biocompatibility Testing | Testing and analysis of the Current Health System has demonstrated compliance to ISO 10993-1: Biological evaluation of medical devices – Guidance | Passed | | SpO2 Testing Validation of the accuracy of SpO2 monitoring | Ensure the accuracy and communication of the SpO2 functions within the Current Health system as per ISO80601-2-61 and the FDA SpO2 guidance; Pulse Oximeters-Premarket Notification Submissions Guidance for Industry and Food and Drug Staff, March 4, 2013 | Passed | | Test Name | Test Description…

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub

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Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub

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Submission Summary (Full Text)

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