Regulora™ is a prescription-only digital therapeutic device intended to provide behavioral therapy through gut-directed hypnotherapy for adults 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Regulora is indicated as a 3-month treatment for patients with abdominal pain due to IBS and is intended to be used together with other IBS treatments.

Device Description

Regulora™ is prescription-only digital therapeutic software indicated for use in the treatment of abdominal pain due to Irritable Bowel Syndrome (IBS). The Regulora program is Software as a Medical Device (SaMD) that resides on and is accessed through the user's mobile device and can be executed at home. Regulora digitizes scripted therapist-administered GDH behavior therapy and provides 7 unique treatment sessions, each lasting ~30 minutes, every other week over 12 weeks. The treatment sessions are designed to first induce deep physical and autonomic relaxation which is followed by metaphorical storytelling and a combination of direct and indirect suggestions targeted at somatic control mechanisms. Regulora also provides for IBS symptom tracking, which patients can share with their doctor in the management of their IBS.

AI/ML Overview

The provided text describes the Regulora™ device, a prescription-only digital therapeutic for Irritable Bowel Syndrome (IBS), and outlines its performance and supporting studies for FDA clearance.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a separate table within the document. However, based on the narrative, the primary clinical acceptance criteria for Regulora are related to improvements in abdominal pain intensity scores, as specified in the "Performance Testing - Clinical" section. The document also mentions Special Controls for product code QMY, which involve:

Clinical data describing a model of therapy (validated in a clinical trial).
Software development documentation (SRS, SDS, V&V, hazard analysis).
Usability assessment.
Labeling.

The reported device performance is primarily based on the EASITx clinical trial.

Acceptance Criteria (Implied)	Reported Device Performance (EASITx Clinical Trial)
Achieve clinically meaningful reduction in abdominal pain intensity scores.	Primary Endpoint (4-week off-treatment period): 30.4% of Regulora group vs. 27.1% of control group experienced ≥ 30% reduction in abdominal pain intensity scores (p = 0.5352) - did not achieve statistical significance.On-Treatment Period (weeks 1-12):- Final 4 weeks of treatment: 30.9% of Regulora group vs. 21.5% of control group experienced ≥ 30% reduction.- Throughout weeks 1-12: 29.3% of Regulora group vs. 18.8% of control group experienced ≥ 30% reduction. Regulora demonstrates clinically meaningful results within the intended use population.
Demonstrate within-group improvement from baseline in IBS symptoms.	Within-Group Improvement (Regulora group, 4-week post-treatment):- 44.9% experienced ≥ 30% improvement in proportion of stools with normal consistency.- 50.3% were either a pain or stool responder (compared to 47% in predicate device).- IBS-D subgroup (N=56): 48.2% experienced ≥ 50% reduction in days with loose or watery stools.- IBS-C subgroup: 39.7% experienced ≥ 1 increased bowel movement per week.- 64.0% reported Adequate Relief.- 67.7% reported overall satisfaction.Note: These measures did not show statistically significant separation from control and therefore associated endpoints were not met.
Absence of serious adverse events related to treatment.	No treatment-related serious adverse events reported.
Minimal non-serious adverse events related to treatment.	Non-serious adverse events with reasonable possible relation to treatment: headache (0.5%, n=1), fatigue (0.5%, n=1), abdominal pain (0.5%, n=1), constipation (0.5%, n=1).
Ability of subjects to use the program in the intended use environment (mobile device at home).	Clinical data showed study subjects could use the program by downloading, installing, and using Regulora on their mobile device at home.
Compliance with Special Controls (pertaining to clinical data, software development, usability, labeling).	MetaMe complies with the special controls for product code QMY. Clinical data provided, software documented (SRS, SDS, V&V, hazard analysis), usability assessment performed, and labeling includes required instructions, warnings, and clinical summary.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: The "Performance Testing - Clinical" section states that 362 evaluable adult subjects with IBS were randomized 1:1 to either the Regulora group (n=181) or the control group (n=181). This entire cohort serves as the test set for evaluating the device's clinical performance.
Data Provenance: The document does not explicitly state the country of origin. However, the study is referred to as the "EASITx clinical trial (Efficacy and Safety of IBS Digital GDH Treatment, EASITx -NCT04133519)", and NCT numbers are typically assigned to clinical trials registered on ClinicalTrials.gov, which often include studies conducted within the U.S. and internationally. The study design (randomized, controlled trial) indicates it is a prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The concept of "ground truth" concerning patient outcomes (like IBS symptom improvement) is typically established through patient-reported outcomes (PROs) using validated questionnaires and scales, rather than expert consensus on individual cases. The document mentions "clinically validated independent instruments" for measuring outcomes but does not refer to a panel of experts establishing the ground truth for each patient's reported symptoms or improvement. The "ground truth" for efficacy in this context is the patient's change in symptoms as measured by these validated scales.

4. Adjudication Method for the Test Set

As the "ground truth" is predominantly based on patient-reported outcomes from validated instruments, there is no mention of an adjudication method (like 2+1 or 3+1) for the test set. Adjudication methods are typically employed when expert interpretation of data (e.g., medical images) is required to establish ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study involving human readers or AI assistance in interpretation was not done. Regulora is a digital therapeutic device that delivers behavioral therapy directly to the patient; it is not an AI-powered diagnostic or interpretive tool that assists human "readers" (e.g., radiologists). Therefore, this question is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, a "standalone" performance evaluation was done. Regulora is designed as a direct-to-patient digital therapeutic. Its clinical performance, as assessed in the EASITx trial, is the outcome of the algorithm/program itself delivering the gut-directed hypnotherapy. There isn't a human-in-the-loop scenario where a clinician is interpreting output from Regulora; rather, Regulora is the intervention. The study directly measures the effect of the Regulora program on patient outcomes.

7. The Type of Ground Truth Used

The ground truth used for clinical efficacy evaluation is based on patient-reported outcomes (PROs) derived from validated instruments and definitions. Specifically, the primary endpoint was a "clinically meaningful 30% reduction in abdominal pain intensity scores," following FDA guidance for Irritable Bowel Syndrome. Other measures included improvements in stool consistency, responder rates (pain or stool), and Adequate Relief, all of which are patient-reported metrics.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" in the context of machine learning model development. Regulora delivers pre-scripted, therapist-administered GDH behavioral therapy; it is described as digitizing existing therapy. While software development involves training for various components, there's no indication of a machine learning model being trained on a specific patient data set to generate the therapy content or personalize it in a way that requires a separate "training set" in the common AI/ML sense. The clinical trial data (n=362) served as the validation set for the device's efficacy.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" for an AI/ML model to generate therapy is not explicitly mentioned as being part of Regulora's development, the establishment of ground truth for such a set is not detailed. The therapy itself (Gut-Directed Hypnotherapy) is established behavioral therapy, and the "ground truth" for its effectiveness comes from existing medical literature and clinical practice, which informed the content digitized by Regulora.

Summary

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November 24, 2021

metaMe Health, Inc. Nandini Murthy Regulatory Consultant 222 W. Merchandise Mart Plaza - Suite 1230 Chicago, IL 60654

Re: K211463

Trade/Device Name: Regulora™ Regulation Number: 21 CFR§ 876.5960 Regulation Name: Computerized Behavioral Therapy Device For Treating Symptoms Regulatory Class: II Product Code: QMY Dated: October 25, 2021 Received: October 26, 2021

Dear Nandini Murthy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211463

Device Name Regulora™

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image: metaMe Health logo	Regulora, FDA 510(k) SubmissionSection 5: 510(k) Summary
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Section 5 – 510(k) Summary -Regulora-

Title:	Regulora ™
Submitter:	metaMe Health, Inc.222 W Merchandise Mart PlazaSuite 1230Chicago, IL 60654(888) 463-8263Email: info@metamehealth.com www.metamehealth.com
Contact:	Nandini MurthyRegulatory ConsultantPhone: 781-710-5378Email: nmurthy@enemconsulting.com
Date Prepared:	October 24, 2021
Device Trade Name:	Regulora ™
Device Common Name:	Prescription Digital Therapeutic Device
Classification Panel:	Gastroenterology/Urology
Classification Regulation:	21 CFR 876.5960, Class II Medical Device (Product Code:QMY)
Classification Name:	Computerized behavioral therapy device fortreating symptoms
Predicate Device:	Parallel, DEN200029

Device Description

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metaMe Health	Regulora, FDA 510(k) Submission
	Section 5: 510(k) Summary

direct and indirect suggestions targeted at somatic control mechanisms. Regulora also provides for IBS symptom tracking, which patients can share with their doctor in the management of their IBS.

Indications for Use

Requlora™ is a prescription-only digital therapeutic device intended to provide behavioral therapy through gut-directed-hypnotherapy for adults 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Regulora is indicated as a 3-month treatment for patients with abdominal pain due to IBS and is intended to be used together with other IBS treatments.

Rationale for Substantial Equivalence

Requlora™ shares the same intended use and technical characteristics of Parallel. Both are prescription digital therapeutics, both are computerized behavior therapy, both are intended to treat gastrointestinal conditions, and both comply with the special controls for product code QMY. Below is a table summarizing the comparison of the devices:

Specifications /Devices	Regulora™	Parallel(Predicate Device)
FDA Clearance	K211463	DEN200029
Regulation	21 CFR 876.5960QMY	21 CFR 876.5960QMY
Intended Use	A computerized behavioral therapydevice for treating symptoms ofgastrointestinal conditions is aprescription device intended toprovide a computerized version ofcondition-specific therapy as anadjunct to standard of caretreatments to patients withgastrointestinal conditions.	A computerized behavioral therapydevice for treating symptoms ofgastrointestinal conditions is aprescription device intended toprovide a computerized version ofcondition-specific therapy as anadjunct to standard of caretreatments to patients withgastrointestinal conditions.
Indications for Use	Regulora is a prescription-onlydigital therapeutic device intendedto provide behavioral therapythrough gut-directed hypnotherapyfor adults 22 years of age and olderwho have been diagnosed withIrritable Bowel Syndrome (IBS).Regulora is indicated as a 3 monthtreatment for patients withabdominal pain due to IBS and isintended to be used together withother IBS treatments.	Parallel is a prescription-only digitaltherapeutic device intended toprovide cognitive behavioral therapyfor adults aged 22 years of age andolder who have been diagnosedwith Irritable Bowel Syndrome (IBS).Parallel is indicated as a 3 monthtreatment for patients with IBS.Parallel treats IBS by reducing theseverity of symptoms and isintended to be used together withother IBS treatments.

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metaMe Health

Regulora, FDA 510(k) Submission Section 5: 510(k) Summary

System	Prescription Digital Therapeuticmobile application designed todeliver Behavioral Therapy throughGut-Directed-Hypnotherapy (GDH)via a mobile app that is downloadedonto a patient's mobile device	Prescription Digital Therapeutic webapplication designed to deliverCognitive Behavioral Therapy (CBT)via the patient's desktop or laptopcomputer's web browser withtherapist involvement
Platform	iOS / Android mobile devices	Microsoft Windows / MacOS laptopor desktop computers
Patient Population	Adults, 22 years of age or olderdiagnosed with IBS	Adults, 22 years of age or olderdiagnosed with IBS
Adjunctive Usage	Intended to provide BehavioralTherapy through Gut-Directed-Hypnotherapy (GDH) as an adjunctto other IBS treatments	Intended to provide CognitiveBehavioral Therapy (CBT) as anadjunct to other IBS treatments
Treatment Duration	3 months	3 months

The Regulora Software as a Medical Devices (SaMD) was developed under a 21 CFR part 820 quality management system, in accordance with the IEC 62304 standard for medical device software lifecycle management, and within an ISO 14971 risk management framework. Regulora was further reviewed according to the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device" and the software was found to have a moderate level of concern. FDA review of the design, development, verification, and validation documentation provided in support of Regulora was found to be acceptable. Additionally, metaMe complies with the special controls for product code QMY, Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions, pertaining to clinical data, software development documentation, useability assessment, and labeling of this prescription device.

Compatible Devices

Regulora is compatible with smartphones, tablets, and other mobile devices that are connected to the internet. Specifically:

iOS devices

Operating System: iOS 12.4 or later
Processor: 1.4 GHz minimum
Memory (RAM): 1 GB minimum
Examples of minimally compatible models: iPhone 6 or later; iPad Air 2 and iPad Mini 4 or later

Android devices

Operating System: Android 8 or later
Processor: 1.8 GHz minimum

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. Memory (RAM): 2 GB minimum
0 Examples of minimally compatible models: Samsung Galaxy S8, LG G5, Motorola Moto G7 or later

Network Connection and Speed

Wi-Fi network or cellular data network
Minimum 2 Mbps (megabits per second; for example 4G)
Recommended 5 Mbps or greater (for example LTE, 5G or Wi-Fi)

Performance Testing - Bench:

In addition to the software verification testing, metaMe emphasizes performance bench testing to measure the performance characteristics of Regulora. Performance tests include:

Uptime Testing - to ensure Regulora is accessible to and functional for patients
Stress Testing - to ensure platform will support all prescribed patients at any given time
Operating System Testing - to ensure Regulora is supported by the most recent iOS and Android operating system releases
Cybersecurity considerations were addressed both via design specifications and bench testing.

Performance Testing - Clinical:

In the EASITx clinical trial (Efficacy and Safety of IBS Digital GDH Treatment, EASITx -NCT04133519), evaluable adult subjects with IBS (n=362) were randomized 1:1 to receive either 12 weeks of Regulora digital remotely-administered GDH behavioral therapy (n=181) or digital remotely-administered muscle relaxation therapy (MR) as a control (n=181). The primary endpoint was abdominal pain, the IBS symptom that most often prompts clinical consultation [3]. The EASITx primary outcome compared a 4-week pre-treatment period to a 4-week offtreatment period that began after completion of the Regulora program. During this offtreatment period (the primary outcome), 30.4% of subjects in the Requlora group and 27.1% of the subjects in the control group experienced at least a clinically meaningful 30% reduction in abdominal pain intensity scores2 (p = 0.5352), not achieving statistical significance. However, during the on-treatment period (weeks 1-12), two separate analyses of the primary endpoint of abdominal pain achieved clinically significant separation from the EASITx control arm. During the final 4 weeks of treatment, a pre-specified endpoint, 30.9% of subjects in the GDH (Regulora) group and 21.5% of the subjects in the control group experienced at least a clinically meaningful 30% reduction in abdominal pain intensity scores. Throughout the on-treatment period (weeks 1-12), 29.3% of subjects in the Regulora group and 18.8% of the subjects in the MR group experienced at least a clinically meaningful 30% reduction in abdominal pain intensity scores. Thus, as with the predicate device (Parallel) [1,2], Requlora demonstrates clinically meaningful results within the intended use population.

4 The pain and stool responder definitions of a 30% improvement from baseline for Regulora follows the FDA Guidance for Industry, Irritable Bowel Syndrome — Clinical Evaluation of Drugs for Treatment, May 2012.

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In addition to the between-group analyses described above, subjects assigned to Requlora experienced clinically meaningful within-group improvement from baseline in IBS symptoms following 12 weeks of treatment, although these measures did not show statistically significant separation from control and therefore the associated endpoints were not met. As measured with clinically validated independent instruments over a 4-week post-treatment period, 44.9% of subjects experienced at least a 30% improvement in the proportion of stools with normal consistency. Half of subjects (50.3%) were either a pain or stool responder, while a 47% responder rate was reported in the predicate device. In the IBS-D subgroup (N=56), 48.2% of participants experienced at least a 50% reduction in days with loose or watery stools, while in the IBS-C subgroup, 39.7% of participants experienced at least 1 increased bowel movement per week. Additionally, 64.0% reported Adequate Relief and 67.7% of subjects reported overall satisfaction with the Regulora treatment.

There were no treatment-related serious adverse events. Non-serious adverse events with a reasonable possible relation to treatment included headache (0.5%, n=1), fatigue (0.5%, n=1), abdominal pain (0.5%, n=1), and constipation (0.5%, n=1).

The clinical data also showed that study subjects could use the program in the intended use environment by downloading, installing, and using Regulora on their mobile device at home.

Special Controls

metaMe complies with the special controls for product code QMY, Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions, pertaining to clinical data, software development documentation, useability assessment, and labeling of this prescription device.

Clinical data were provided that describe a model of therapy for the indicated gastrointestinal conditions.
0 The model was further validated in a clinical trial of Regulora with validated clinical endpoints, demonstrating clinically meaningful results within the intended use population.
o All adverse events resulting from the clinical trial were evaluated.
0 The Software was described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis was performed. Software documentation demonstrated that the device effectively implements the behavioral therapy model.
Usability assessment demonstrated that the intended user can correctly use the device.

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metaMe Health

Labeling includes instructions for use, with images that demonstrate how to interact with the device along with a list of the minimum operating system requirements that support the software of the device, a warning that the device is not intended for use in lieu of a standard therapeutic intervention or represent a substitution for the patient's medication, a warning to seek medical care if a patient has feelings or thoughts of harming themselves or others; and a summary of the clinical testing with the device.

Conclusion

Regulora meets the threshold of substantial equivalence to the predicate device. From a design and clinical perspective, Regulora and Parallel (predicate device) have the same technological characteristics and share the same intended use. Both are prescription digital therapeutics, both are computerized behavior therapy, and both are intended to treat one or more gastrointestinal conditions. Software design, development, and verification along with bench and clinical performance testing validates Regulora for its intended use. Regulora meets the Special Controls as defined in 21 CFR 876.5960 (QMY) for clinical data, software design lifecycle documentation, patient usability, and device labeling. Regulora demonstrates clinically meaningful results within the intended use population.

Reference List

1. Everitt H, Landau S, Little P, et al. Therapist telephone-delivered CBT and web-based CBT compared with treatment as usual in refractory irritable bowel syndrome: the ACTIB three-arm RCT. Health Technol Assess. 2019;23(17):1-154. doi:10.3310/hta23170
1. Everitt H, Landau S, Little P, et al; ACTIB trial team. Assessing Cognitive behavioural therapy in irritable bowel (ACTIB): protocol for a randomised controlled trial of clinicaleffectiveness and cost-effectiveness of therapist delivered cognitive behavioural therapy and web-based self-management in irritable bowel syndrome in adults. BMJ Open. 2015;5(7):e008622. doi:10.1136/bmjopen-2015-008622.
1. Hungin AP, Chang L, Locke GR, Dennis EH, Barghout V. Irritable bowel syndrome in the United States: prevalence, symptom patterns and impact. Aliment Pharmacol Ther. 2005 Jun 1;21(11):1365-75. doi: 10.1111/j.1365-2036.2005.02463.x. PMID: 15932367.

Regulation Number and Section

§ 876.5960 Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions.

(a)
Identification. A computerized behavioral therapy device for treating symptoms of gastrointestinal conditions is a prescription device intended to provide a computerized version of condition-specific therapy as an adjunct to standard of care treatments to patients with gastrointestinal conditions.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must be provided to fulfill the following:
(i) Describe a model of therapy for the indicated gastrointestinal conditions;
(ii) Validate the model of therapy as implemented by the device using a clinically defined endpoint; and
(iii) Evaluate all adverse events.
(2) Software must be described in detail in the software requirements specification and software design specification. Software verification, validation, and hazard analysis must be performed. Software documentation must demonstrate that the device effectively implements the behavioral therapy model.
(3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
(4) Labeling:
(i) Labeling must include instructions for use, including images that demonstrate how to interact with the device;
(ii) Patient and physician labeling must list the minimum operating system requirements that support the software of the device;
(iii) Patient and physician labeling must include a warning that the device is not intended for use in lieu of a standard therapeutic intervention or to represent a substitution for the patient's medication;
(iv) Patient and physician labeling must include a warning to seek medical care if a patient has feelings or thoughts of harming themselves or others; and
(v) Physician and patient labeling must include a summary of the clinical testing with the device.

Indications for Use

Indications for Use (Describe)

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Section 5 – 510(k) Summary -Regulora-

Device Description

Indications for Use

Rationale for Substantial Equivalence

Regulora, FDA 510(k) Submission Section 5: 510(k) Summary

Compatible Devices

Performance Testing - Bench:

Performance Testing - Clinical:

Special Controls

Conclusion

Reference List

§ 876.5960 Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions.

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