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NxGen Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment.
The device is designed for children greater than five years of age, adolescent and adult subjects.
SAFEY MEDICAL DEVICES PRIVATE LIMITED
165253
In Commercial Distribution
- 00860013746407 ()
- Weight: 300 Gram
- Expiratory peak flow meter, digital
MamaLift Plus is a digital therapy designed to treat symptoms of postpartum depression by delivering evidence-based therapeutic components of Cognitive Behavioral Therapy via software on a mobile application, such as a smartphone or tablet.
Curio Digital Therapeutics Inc.
MamaLift Plus
In Commercial Distribution
- 00860012970308 ()
- Mental health/function therapeutic software, screen-viewed
Tempus ECG-AF is a cardiovascular machine learning-based notification software intended to analyze recordings of 12-lead ECG devices from patients 65 years of age and older. The software employs machine learning techniques to analyze ECG recordings and detect signs associated with a patient experiencing atrial fibrillation and/or atrial flutter (collectively referred to as AF) within the next 12 months. The device is designed to extract otherwise unavailable information from ECGs conducted under the standard of care, to help health care providers better identify patients who may be at risk for undiagnosed AF in order to evaluate them for referral of further diagnostic follow up and address the unmet need of reducing the number of undiagnosed AF patients.
Tempus AI, Inc.
3
In Commercial Distribution
- 00860011843603 ()
- Cardiopulmonary physiological parameter analysis software
BT-001 (AspyreRx) is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to treat patients 18 years or older with type 2 diabetes.
Better Therapeutics, Inc.
ma.1.0.0
In Commercial Distribution
- 00860011146704 ()
- Mental health/function therapeutic software, screen-viewed
The Humero Tech C1 HD is an updated version of the Humero Tech C1 to better withstand strength and conditioning activities in addition to rehabilitation. The C1 HD is a seated apparatus capable of completing a vast number of shoulder rehabilitation and strengthening exercises. This device has the capability to be utilized in low level rehabilitation and strengthening progressing to more functional and dynamic activities. The Humero Tech C1 HD has an intended us of assisting with improving the strength, active range of motion, and motor control of the postoperative status, or when a deficit in power is noted. The device collects data and tracks range of motion to evaluate progress over time.
Titin Km Biomedical Corp.
C1 HD
In Commercial Distribution
- 00860010519912 ()
A2-0000
- Virtual-display rehabilitation system, passive-support, upper-limb
The Humero Tech C1 has been developed as a solution for the current limitations with shoulder rehabilitation. The C1 is a seated apparatus capable of completing a vast number of shoulder rehabilitation and strengthening exercises. This device has the capability to be utilized in low level rehabilitation and strengthening progressing to more functional and dynamic activities. The Humero Tech C1 has an intended use of assisting with improving the strength, active range of motion, and motor control of the shoulder complex. Furthermore, the indications for use will be any individual suffering from a shoulder pathology, including postoperative status, or when a deficit in power is noted. The device collects data and tracks range of motion to evaluate progress over time.
Titin Km Biomedical Corp.
C1
In Commercial Distribution
- 00860010519905 ()
A1-0000
- Virtual-display rehabilitation system, passive-support, upper-limb
A self-guided digital Acceptance and Commitment Therapy, a form of Cognitive Behavioral Therapy intended for the treatment of fibromyalgia symptoms. It is used by the patient at home or any out of clinic setting to reinforce their skills in acceptance and commitment therapy.
Swing Therapeutics, Inc.
1.2
In Commercial Distribution
- 00860010446324 ()
- Mental health/function therapeutic software, screen-viewed
A self-guided digital Acceptance and Commitment Therapy, a form of Cognitive Behavioral Therapy intended for the treatment of fibromyalgia symptoms. It is used by the patient at home or any out of clinic setting to build their skills in acceptance and commitment therapy.
Swing Therapeutics, Inc.
1.2
In Commercial Distribution
- 00860010446317 ()
- Mental health/function therapeutic software, screen-viewed
No Description
Balance Tracking Systems Incorporated
BTRACKS-50
In Commercial Distribution
- 00860010129104 ()
- Posturography system platform
The VISIONAIR™ system is a software application intended to be used with third-party endoscopic systems in the measurement of the nasal respiratory airway. The VISIONAIR™ system measures the nasal respiratory airway from the endoscopic images taken in the region of the internal nasal valve (INV) and nasal cavum (NC).
PACIFICMD BIOTECH, LLC
2
In Commercial Distribution
- 00860009626805 ()
- Computerized rhinomanometer