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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 Size Type Device Class Implantable

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Software
PRECISION BIOMETRICS INC
Feature Pack G
In Commercial Distribution

  • 00853818007392 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack E
In Commercial Distribution

  • 00853818007101 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack D
In Commercial Distribution

  • 00853818007095 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack C
In Commercial Distribution

  • 00853818007088 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack B
In Commercial Distribution

  • 00853818007071 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack A
In Commercial Distribution

  • 00853818007064 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Apricot
In Commercial Distribution

  • 00853818007057 ()


  • Bioelectrical signal analysis software
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® 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
REMI Vigilenz AI for Event Detection
Epitel, Inc.
1.x.x
In Commercial Distribution

  • 00860005388189 ()
20104

  • Bioelectrical signal analysis software
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