Inspire 4063

GUDID 00855728005185

The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bipolar configuration, which means the center electrode is connected to one pole of the stimulation (e.g., negative pole), and is flanked on each side by two electrodes connected to the opposite pole of stimulation (e.g., positive pole). It is packaged with a tunneling rod to facilitate the implant procedure. The cuff is surgically positioned around a patient’s hypoglossal nerve, and the connector end of the lead is connected to the IPG. The cuff electrodes apply electrical current that stimulates the nerve causing the tongue to move forward. The tongue movement (via genioglossus and other tongue protrusor muscle contraction) serves to maintain an open airway. The figure below provides an illustration of the Model 4063 stimulation lead.

INSPIRE MEDICAL SYSTEMS INC

Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Primary Device ID00855728005185
NIH Device Record Keydbb75cd2-aaec-4013-928c-2f9d1de9c088
Commercial Distribution StatusIn Commercial Distribution
Brand NameInspire
Version Model Number900-001-007
Catalog Number4063
Company DUNS012419779
Company NameINSPIRE MEDICAL SYSTEMS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100855728005185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNQStimulator, Hypoglossal Nerve, Implanted, Apnea

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-05
Device Publish Date2017-10-02

On-Brand Devices [Inspire]

10855728005632The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. T
00855728005437The Model 3024 Inspire II IPG contains electronics and a battery that are sealed inside a titani
00855728005413The Model 2740 physician programmer is designed for use by a physician to non‐invasively inter
00855728005338The Model 2740 physician programmer is designed for use by a physician to non‐invasively inter
00855728005307The Model 2740 physician programmer is designed for use by a physician to non‐invasively inter
00855728005277The Model 2740 physician programmer is designed for use by a physician to non‐invasively inter
00855728005253The sleep remote is an external device that is about the size of a cell phone and is used by the
00855728005222The sleep remote is an external device that is about the size of a cell phone and is used by the
00855728005192The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. T
00855728005185The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bip
00855728005109The Model 2740 physician programmer is designed for use by a physician to non-invasively interro
00855728005093The Model 2740 physician programmer is designed for use by a physician to non-invasively interro
00855728005055The Model 2740 physician programmer is designed for use by a physician to non-invasively interro
00855728005031The patient programmer is an external device that is about the size of a cell phone or PDA, and
00855728005024The Model 3024 Inspire II IPG contains electronics and a battery that are sealed inside a titani
00855728005017The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bip
00855728005000The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. T
10855728005533The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bip
10855728005656The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. T
00855728005642The Model 2740 physician programmer is designed for use by a physician to non invasively interro
00855728005611The sleep remote is an external device that is about the size of a cell phone and is used by the
00855728005598The sleep remote is an external device that is about the size of a cell phone and is used by the
00855728005550The Model 2740 physician programmer is designed for use by a physician to non invasively interro
10855728005465The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. T
10855728005410The Model 2740 physician programmer is designed for use by a physician to non‐invasively inter
10855728005403The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. T
10855728005397The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bip
10855728005366The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. T
10855728005199The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. T
10855728005182The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bip
10855728005670The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bip

Trademark Results [Inspire]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INSPIRE
INSPIRE
98407977 not registered Live/Pending
Sahara Group LLC
2024-02-16
INSPIRE
INSPIRE
98373585 not registered Live/Pending
STX SOFTWARE, LLC
2024-01-24
INSPIRE
INSPIRE
98223123 not registered Live/Pending
1426391 B.C. LTD.
2023-10-13
INSPIRE
INSPIRE
98074438 not registered Live/Pending
Megan Mae Beauty Products LLC
2023-07-07
INSPIRE
INSPIRE
98071172 not registered Live/Pending
Authentic Walk Creative Inc.
2023-07-05
INSPIRE
INSPIRE
98003183 not registered Live/Pending
TDC Development, Inc.
2023-05-18
INSPIRE
INSPIRE
97739001 not registered Live/Pending
Inspire To Better LLC
2023-01-02
INSPIRE
INSPIRE
97587138 not registered Live/Pending
Inspire Event Technologies, LLC
2022-09-12
INSPIRE
INSPIRE
97587127 not registered Live/Pending
Inspire Event Technologies, LLC
2022-09-12
INSPIRE
INSPIRE
97475178 not registered Live/Pending
JJ Acquisition, LLC
2022-06-24
INSPIRE
INSPIRE
97327228 not registered Live/Pending
Inspire Brands, Inc.
2022-03-23
INSPIRE
INSPIRE
97194489 not registered Live/Pending
O'Driscoll, Peter
2021-12-29

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