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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Class Implantable

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Interacoustics - 05711117180565

No Description
Interacoustics A/S
EyeSeeCam
In Commercial Distribution

  • 05711117180565 ()


  • Eye movement analysis system

Parallel(TM) - 00860006172008

ParallelTM is a Prescription Digital Therapeutic (PDT) web application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS).
Mahana Therapeutics, Inc.
01-0001-001
In Commercial Distribution

  • 00860006172008 ()
01-0001-001

  • Mindfulness/behavioural therapy software, non-clinician-consultative

Regulora® - 00860005970209

Regulora® is prescription-only digital therapeutic (PDT) software indicated for use in the treatment of abdominal pain due to Irritable Bowel Syndrome (IBS). The Regulora program is Software as a Medical Device (SaMD) that resides on and is accessed through the user’s mobile device and can be executed at home. Regulora digitizes scripted therapist-administered gut-directed psychotherapy and provides 7 unique treatment sessions, each lasting ~30 minutes, every other week over 12 weeks. The treatment sessions are designed to first induce deep physical and autonomic relaxation which is followed by metaphorical storytelling and a combination of direct and indirect suggestions targeted at somatic control mechanisms. Regulora also provides for IBS symptom tracking, which patients can share with their doctor in the management of their IBS.
Metame Health, Inc.
GDH-1
In Commercial Distribution

  • 00860005970209 ()
60005-97020

  • Mindfulness/behavioural therapy software, non-clinician-consultative

MedTrakVNG Goggle - B292M9205200

No Description
MEDTRAK VNG, INC.
M920520
In Commercial Distribution

  • B292M9205200 ()


  • Eye movement analysis system

MedTrakVNG Interface Controller - B292M9203020

No Description
MEDTRAK VNG, INC.
M920302
In Commercial Distribution

  • B292M9203020 ()


  • Eye movement analysis system

MobiTrakVNG Receiver - B292M9174150

No Description
MEDTRAK VNG, INC.
M917415
In Commercial Distribution

  • B292M9174150 ()


  • Eye movement analysis system

MobiTrak Software v3.00 - B292M9170810

No Description
MEDTRAK VNG, INC.
M917081
In Commercial Distribution

  • B292M9170810 ()


  • Eye movement analysis system

MedTrakVNG Footswitch - B2924091070

No Description
MEDTRAK VNG, INC.
40-9107
In Commercial Distribution

  • B2924091070 ()


  • Eye movement analysis system

MedTrakVNG MobiTrak System - B2924040100

No Description
MEDTRAK VNG, INC.
40-4010
In Commercial Distribution

  • B2924040100 ()


  • Eye movement analysis system

Eye Tracker Camera - 07090042052023

No Description
Nordicneurolab AS
ETC 2.0
In Commercial Distribution

  • 07090042052023 ()


  • Eye movement analysis system
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