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SuRgical Planner (SRP) BrainStorm Desktop System
SURGICAL THEATER LLC
BrainStorm
In Commercial Distribution
- 00860003884119 ()
- Surgical simulation system
SyncAR Surgical Navigation Advanced Platform (SNAP) Operating Room System
SURGICAL THEATER LLC
SyncAR
In Commercial Distribution
- 00860003884102 ()
- Surgical planning/navigation-enhancement system
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
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 ReWalk 7 Personal Exoskeleton is a wearable, battery-powered prescription device intended for use by certified individuals at least 18 years old with lower limb disability to perform routine ambulatory functions at home and in the community. Control of the exoskeleton is achieved through a user-worn wireless, web connected wrist control unit (WCU), a wireless crutch-mounted control unit (CCU), and specific body movements as measured through a tilt sensor. The powered device movements are performed by a set of gears and motors at the knee and the hip joints. The ReWalk 7 Personal Exoskeleton includes the exoskeleton (incl. rigid frames, waist pack, and straps), battery power supply, crutches with integrated powered crutch control add-on unit (CCU), and the Wrist Control Unit (WCU). The wireless, web connected therapist handheld device (THD) is used by certified therapists for device configuration and control. All ReWalk 7 Personal Exoskeleton components are suitable for indoor and outdoor use. The ReWalk use includes standing, walking on level surfaces, mild slopes, ascending and descending stairs and curbs.
LIFEWARD LTD
ReWalk 7
In Commercial Distribution
- 00860001744514 ()
50-20-0005
- Programmable ambulation exoskeleton, home-use
Disposable snap that snaps onto a Jamshidi for instrument tracking.
TrackX Technology, LLC
HANG-TEN SNAP
Not in Commercial Distribution
- 00860099000899 ()
- 00860099000882 ()
TX-3-3070
- Diagnostic x-ray digital imaging system workstation application software
TrackX Software
TrackX Technology, LLC
TrackX Software
In Commercial Distribution
- 00860099000837 ()
N/A
- Diagnostic x-ray digital imaging system workstation application software
Disposable snap that snaps onto a Jamshidi for instrument tracking.
Instrument Tracker .125 IN
(previously known as Snap 2 or 12)
TrackX Technology, LLC
T SNAP
Not in Commercial Distribution
- 00860099000813 ()
- 00860099000875 ()
TX-3-3038
- Diagnostic x-ray digital imaging system workstation application software
Optical Tracker Snap 11 0.090 IN
(previously known as Snap 1)
TrackX Technology, LLC
Snap 11
Not in Commercial Distribution
- 00860099000806 ()
TX-3-3036
- Diagnostic x-ray digital imaging system workstation application software