FDA.reportPublic FDA data

Mahana IBS

Primary DI
00860006172015
Brand
Mahana IBS
Company
Mahana Therapeutics, Inc.
Model
01-0003-001
Catalog number
01-0003-001
Device description
Mahana IBS is a prescription Digital Therapeutic (PDT) mobile application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS).
Published
2021-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QMYComputerized Behavioral Therapy Device For Treating Symptoms

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMYComputerized Behavioral Therapy Device For Treating SymptomsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211372000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211372000Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)Mahana Therapeutics, Inc.2021-06-02QMY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006172015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006172015008600061720158600061720150860006172015

GMDN Terms#

Term, Definition table
TermDefinition
Mindfulness/behavioural therapy software, non-clinician-consultativeA software program intended to be used with an off-the-shelf computer/tablet/smartphone to help treat affective/mood disorders, stress, and/or other disorders related to or caused by these, by providing a patient with on-screen therapeutic exercises (e.g., mindfulness, mental imagery, cognitive behavioural therapy) often with educational information; it is not dedicated to exposure therapy. It is intended for use by a patient at home and is not based on consultation with a clinician.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(844) 624-2620support@mahanatherapeutics.com

Regulatory Flags#

DUNS number
081128158
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860006172008Parallel(TM)01-0001-00101-0001-0012021-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860005970209Regulora®Metame Health, Inc.QMY2022-04-29
00860006172008Parallel(TM)Mahana Therapeutics, Inc.QMY2021-03-18