Parallel(TM) 01-0001-001

GUDID 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.

Mindfulness/behavioural therapy software, non-clinician-consultative

• Primary Device ID: 00860006172008
• NIH Device Record Key: 685638e8-f631-44bf-9116-56ee90e2f899
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parallel(TM)
• Version Model Number: 01-0001-001
• Catalog Number: 01-0001-001
• Company DUNS: 081128158
• Company Name: Mahana Therapeutics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 844-624-2620
• Email: support@mahanatherapeutics.com
• Phone: 844-624-2620
• Email: support@mahanatherapeutics.com
• Phone: 844-624-2620
• Email: support@mahanatherapeutics.com
• Phone: 844-624-2620
• Email: support@mahanatherapeutics.com
• Phone: 844-624-2620
• Email: support@mahanatherapeutics.com
• Phone: 844-624-2620
• Email: support@mahanatherapeutics.com
• Phone: 844-624-2620
• Email: support@mahanatherapeutics.com
• Phone: 844-624-2620
• Email: support@mahanatherapeutics.com
• Phone: 844-624-2620
• Email: support@mahanatherapeutics.com
• Phone: 844-624-2620
• Email: support@mahanatherapeutics.com
• Phone: 844-624-2620
• Email: support@mahanatherapeutics.com
• Phone: 844-624-2620
• Email: support@mahanatherapeutics.com
• Phone: 844-624-2620
• Email: support@mahanatherapeutics.com
• Phone: 844-624-2620
• Email: support@mahanatherapeutics.com
• Phone: 844-624-2620
• Email: support@mahanatherapeutics.com
• Phone: 844-624-2620
• Email: support@mahanatherapeutics.com
• Phone: 844-624-2620
• Email: support@mahanatherapeutics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006172008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200029

FDA Product Code

• QMY: Computerized Behavioral Therapy Device For Treating Symptoms

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-26
• Device Publish Date: 2021-03-18

Devices Manufactured by Mahana Therapeutics, Inc.

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