Cleared Traditional

K230526 - TEA Device (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K230526 · Transtimulation Research, Inc. · Gastroenterology & Urology device
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Sep 2023
Decision
199d
Days
Class 2
Risk

K230526 is an FDA 510(k) clearance for the TEA Device. Classified as Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs) (product code QHH), Class II - Special Controls.

Submitted by Transtimulation Research, Inc. (Oklahoma City, US). The FDA issued a Cleared decision on September 14, 2023 after a review of 199 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5340 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Transtimulation Research, Inc. devices

Submission Details

510(k) Number K230526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2023
Decision Date September 14, 2023
Days to Decision 199 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 130d · This submission: 199d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QHH Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5340
Definition A Non-implanted Nerve Stimulator For Functional Abdominal Pain Relief Is A Device That Stimulates Nerves Remotely From The Source Of Pain With The Intent To Relieve Functional Abdominal Pain. This Generic Type Of Device Does Not Include Devices Designed To Relieve Pelvic Pain.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

AlvaMed, Inc.
Eric Bannon

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT05392439 Completed Interventional

Effect of taVNS on Abdominal Pain and Other Symptoms in Constipation-predominant Irritable Bowel Syndrome

The Efficacy and Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation on Abdominal Pain and Other Symptoms in Patients With Constipation-predominant Irritable Bowel Syndrome

42
Patients (actual)
1
Site
Treatment
Purpose
Single blind
Masking
Condition studied Constipation-predominant Irritable Bowel Syndrome; Abdominal Pain
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Tongji University
Started 2020-03-01 → Primary completion 2020-12-15
Primary outcome
Change in аbdominal pain between sham and active taVNS
Secondary outcome
Change in IBS symptom severity scale (IBS-SSS) between sham and active taVNS
Study completed - no results published. This trial concluded in 2020 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov