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QHHClass II

Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

21 CFR 876.5340 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QHH is the FDA product code for Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs), a class II device type, regulated under 21 CFR 876.5340. FDA's definition for this code reads: "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". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QHH
Device name
Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
FDA 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.
Regulation
21 CFR 876.5340
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code QHH

By decision year
6 clearances under product code QHH with a decision year between 2019 and 2025, 2025 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QHH by decision year
YearClearances
20191
20201
20231
20241
20252

Applicants with the most clearances

Product code QHH
Applicants holding the most 510(k) clearances under product code QHH
ApplicantClearances
Neuraxis, Inc3
Dyansys, Inc.1
Innovative Health Solutions (Ihs), Inc.1
Transtimulation Research Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code