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510(k) Data Aggregation
K Number
DEN180057Device Name
IB-Stim
Manufacturer
Innovative Health Solutions (IHS), Inc.
Date Cleared
2019-06-07
(225 days)
Product Code
QHH
Regulation Number
876.5340Why did this record match?
Applicant Name (Manufacturer) :
Innovative Health Solutions (IHS), Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-Stim is intended to be used for 120 hours per week up to 3 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS.
Device Description
The IB-Stim is a device that delivers electrical stimulation through percutaneous electrodes to areas usually innervated by branches of occipital nerves and cranial nerves V, VII, IX and X that are located by transillumination. The device consists of (1) a percutaneous electrical nerve field stimulator (PENFS), (2) a multi-pin wire harness percutaneous electrode array, and (3) a pen light for use in the transillumination technique that aids in positioning of the percutaneous electrodes (Figure 1).
The wire harness percutaneous electrode array consists of 4 leads. The 1-1-1-4 configuration consists of three single-needle leads, and one 4-needle array (Figure 2).
The stimulator is placed behind the ear and the percutaneous electrodes are positioned utilizing the transillumination function of the device (Figure 1). The transillumination technique assists in the visualization of the vasculature of the ear to aid in the placement of the percutaneous electrodes near the nerve branches in the ear.
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K Number
DEN170018Device Name
NSS-2 System
Manufacturer
Innovative Health Solutions (IHS), Inc.
Date Cleared
2017-11-15
(243 days)
Product Code
PZR
Regulation Number
882.5896Why did this record match?
Applicant Name (Manufacturer) :
Innovative Health Solutions (IHS), Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination.
Device Description
NSS-2 BRIDGE is a device that electrically stimulates branches of Cranial Nerves V. VII. IX and X, and the occipital nerves identified by transillumination through percutaneous electrodes to aid in the reduction of opioid withdrawal symptoms. The device consists of (1) a percutaneous nerve field stimulator (PNFS; Figure 1), (2) a multi-pin wire harness percutaneous electrode array (Figure 2), and (3) a pen light for use in the transillumination technique that aids in positioning of the percutaneous electrodes (Figure 3).
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