Mahana IBS 01-0003-001

GUDID 00860006172015

Mahana IBS is a prescription Digital Therapeutic (PDT) mobile application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS).

Mahana Therapeutics, Inc.

Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative Mindfulness/behavioural therapy software, non-clinician-consultative
Primary Device ID00860006172015
NIH Device Record Keya0e4bc2d-8ac0-4f86-9b36-d814501ae91b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMahana IBS
Version Model Number01-0003-001
Catalog Number01-0003-001
Company DUNS081128158
Company NameMahana Therapeutics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(844) 624-2620
Emailsupport@mahanatherapeutics.com
Phone(844) 624-2620
Emailsupport@mahanatherapeutics.com
Phone(844) 624-2620
Emailsupport@mahanatherapeutics.com
Phone(844) 624-2620
Emailsupport@mahanatherapeutics.com
Phone(844) 624-2620
Emailsupport@mahanatherapeutics.com
Phone(844) 624-2620
Emailsupport@mahanatherapeutics.com
Phone(844) 624-2620
Emailsupport@mahanatherapeutics.com
Phone(844) 624-2620
Emailsupport@mahanatherapeutics.com
Phone(844) 624-2620
Emailsupport@mahanatherapeutics.com
Phone(844) 624-2620
Emailsupport@mahanatherapeutics.com
Phone(844) 624-2620
Emailsupport@mahanatherapeutics.com
Phone(844) 624-2620
Emailsupport@mahanatherapeutics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860006172015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QMYComputerized Behavioral Therapy Device For Treating Symptoms

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-29
Device Publish Date2021-06-21

Devices Manufactured by Mahana Therapeutics, Inc.

00860006172015 - Mahana IBS2021-06-29Mahana IBS is a prescription Digital Therapeutic (PDT) mobile application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS).
00860006172015 - Mahana IBS2021-06-29 Mahana IBS is a prescription Digital Therapeutic (PDT) mobile application designed to deliver Cognitive Behavioral Therapy (CBT)
00860006172008 - Parallel(TM)2021-03-26 ParallelTM is a Prescription Digital Therapeutic (PDT) web application designed to deliver Cognitive Behavioral Therapy (CBT) to
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