Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)

K-Number: K211372 · 2021-06-02

ApplicantMahana Therapeutics, Inc.
Decision Date2021-06-02
Product CodeQMY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) is the device name listed in this FDA 510(k) record. The listed applicant is Mahana Therapeutics, Inc.. It received FDA 510(k) clearance on 2021-06-02 under 510(k) number K211372. The device is classified under product code QMY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)?

Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) is a medical device that received FDA 510(k) clearance on 2021-06-02. The listed applicant is Mahana Therapeutics, Inc.. The 510(k) number is K211372.

When did Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) receive FDA 510(k) clearance?

Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) received FDA 510(k) clearance on 2021-06-02, under 510(k) number K211372.

Who is the listed applicant for Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)?

The FDA 510(k) record lists Mahana Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)?

The FDA product code for Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) is QMY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06681012Gelsectan® in the Treatment of Patients With Diarrhoea-predominant Irritable Bowel SyndromeRECRUITINGNCT07140497Reduction of Anxiety in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching - A Randomized Clinical TrialNOT_YET_RECRUITINGNCT07195292Reduction of Depression in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC CoachingNOT_YET_RECRUITINGNCT07769593MORA Cure for Knee Osteoarthritis With Anterior Knee PainACTIVE_NOT_RECRUITINGNCT06676488A Randomized Crossover Trial of Bright Light Therapy in Irritable Bowel SyndromeCOMPLETEDNCT07581756Repeated Transcranial Magnetic Stimulation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Clinical TrialRECRUITING

Related Devices (Code: QMY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211463ReguloraMetame Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑