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Parallel(TM)

FDA UDI

Class II (US FDA UDI)

by Mahana Therapeutics, Inc.

Identity

Trade Name
Parallel(TM) FDA UDI
Generic Name
Mindfulness/behavioural therapy software, non-clinician-consultative FDA UDI
Device Name
ParallelTM is a Prescription Digital Therapeutic (PDT) web application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS). FDA UDI
Model / Reference
01-0001-001 FDA UDI
Description
ParallelTM is a Prescription Digital Therapeutic (PDT) web application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS). FDA UDI

Identifiers

Catalog Number
01-0001-001 FDA UDI
Primary DI / UDI-DI
00860006172008 FDA UDI
510(k) Number
DEN200029 FDA UDI
FDA Product Code
QMY FDA UDI
GMDN Term
Mindfulness/behavioural therapy software, non-clinician-consultative FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5960 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Mindfulness/behavioural therapy software, non-clinician-consultative

Parallel(TM) by Mahana Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mindfulness/behavioural therapy software, non-clinician-consultative.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mahana Therapeutics, Inc.

Sources (1)

  • FDA UDI 685638e8-f631-44bf-9116-56ee90e2f899 36 fields · synced Jun 8, 2026