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The Surearly SMART Menopause Test works by inserting the test stick into the Test reader, which measures color changes on the test stick. It detects FSH at a concentration
of 25 mIU/mL or greater. The test line utilizes a monoclonal FSH antibody and the test strip contains pre-dried antibodies with gold conjugates. When urine is absorbed, FSH
combines with antibody gold conjugates on the gold conjugate pad. The formed antigen-antibody complexes react with the anti-FSH antibody on the test line, resulting in red or
purple lines. The control line is displayed using goat anti-rabbit IgG antibody. Instead of confusing visual interpretation, the Surearly SMART Menopause Test provides easy-to-read and clear digital results both on the device and the App. The App also provides more information with hormone graphs and additional messages to help your comprehensive management of hormonal health.
Sugentech Inc._Osong Branch
Surearly SMART Menopause Test
In Commercial Distribution
- 08809408863475 ()
- 08809408863512 ()
- Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
The overall intended use of neotivCare is to provide an app-based objective measurement of cognition to quantify cognitive impairment. The software is intended for use by patients at the indication of medical professionals to quantify and monitor a suspected or self-reported cognitive impairment. The app is not intended as a standalone diagnostic assessment and is only indicated as a tool to support the diagnostic process of a medical professional.
neotiv GmbH
1.0.0
In Commercial Distribution
- 04262390860015 ()
- Cognitive assessment software
BabySat unit composed of one base station, one sensor, two socks and the App.
The BabySat 3 pulse oximeter is indicated for use in measuring and displaying functional oxygen
saturation of arterial hemoglobin (SpO2) and Pulse rate. It is indicated for spot-checking and/or
continuous monitoring of well-perfused patients greater than one month old up to 18 months old and
weighing between 6 and 30 lbs., in the home environment
Owlet Baby Care, Inc.
OSS 3.0-M1; OBL 3.0-M1
In Commercial Distribution
- 00810099090086 ()
- 00810099090192 ()
- 10810099090199 ()
- Multiple vital physiological parameter monitoring system, home-use
reSET-O Mobile Application runs on iOS. reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only Mobile Medical Application.
Limitations of Use: reSET-O has not been shown to decrease illicit drug use or improve abstinence in patients with OUD.
PEAR THERAPEUTICS, INC.
1.1
Not in Commercial Distribution
- 10851580008057 ()
N/A
- Mental health/function therapeutic software, screen-viewed
Soovu Pain Relief System is a kit branded as Soovu Heatwave Therapy and includes two 2" x 2" pods/heaters that, when adhered to user's skin via disposable adhesive rings, provide pulsed heat at controlled temperatures for set therapy durations. The pods are Bluetooth-paired with, and controlled via, a mobile device application (Soovu on iOS or Android) from which the user also administers the heat therapy sessions. The Soovu Heatwave Therapy Kit includes 2 heating pods, 1 dual-pod charging cradle, 1 USB charging cable, 60 'Daily' adhesives, carry case, and Quick Start Guide.
Soovu Labs, Inc.
SL-WPTKIT-01
In Commercial Distribution
- 00850014805005 ()
- Electric pad localized-body heating system
The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG management solution. (Medical Device Data System) The light weight and portable Spaulding Electrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph) information to the WebECG system and receives a report back from the WebECG system. The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ or Windows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable and strategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a 12-lead ECG.
SPAULDING MEDICAL
2100iQ
In Commercial Distribution
- B441IQ0 ()
- Electrocardiograph, professional, multichannel
The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG
management solution. (Medical Device Data System) The light weight and portable Spaulding
Electrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph)
information to the WebECG system and receives a report back from the WebECG system.
The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ or
Windows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable and
strategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a
12-lead ECG.
SPAULDING MEDICAL
2100iQ
In Commercial Distribution
- B441BTIEC0 ()
- Electrocardiograph, professional, multichannel
The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG
management solution. (Medical Device Data System) The light weight and portable Spaulding
Electrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph)
information to the WebECG system and receives a report back from the WebECG system.
The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ or
Windows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable and
strategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a
12-lead ECG.
SPAULDING MEDICAL
2100iQ
In Commercial Distribution
- B441BTAHA0 ()
- Electrocardiograph, professional, multichannel
Canvas Dx is a prescription diagnostic aid to healthcare professionals (HCP) considering the diagnosis of Autism Spectrum Disorder (ASD) in patients 18 months through 72 months of age at risk for developmental delay. The patient’s caregiver uses a smartphone application (“App”) to fill out a caregiver questionnaire and to make video recordings of behavior at home, and then the physician fills out a medical questionnaire online. The results are made available to the physician.
Cognoa, Inc.
1.3.0
In Commercial Distribution
- 00860007260605 ()
- Neurodevelopmental disorder interpretive software
The TempShield is a wearable device that senses body temperature and communicates with an app on your smartphone. When the TempShield is connected to your device, it sends all temperature measurements automatically.
You can wear an TempShield for up to 60 days and check your current temperature and temperature measurements history at any time. You have the ability to share the data with your clinician if your clinician has established an AION account.
Aion Biosystems, Inc.
DWF-1824
In Commercial Distribution
- 00197644811199 ()
- Wireless patient thermometer, single-use