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The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-008-051
In Commercial Distribution
- 00855728005253 ()
2500
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-008-000
In Commercial Distribution
- 00855728005222 ()
2500
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The patient programmer is an external device that is about the size of a cell phone or PDA, and is used by the patient to activate the Inspire system before they go to sleep. The patient places the programmer over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation amplitude (within limits set by the physician). The patient programmer also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide confirmation of IPG status (Therapy ON/OFF and Battery Status). The patient programmer will only communicate with the Inspire system IPG
Inspire Medical Systems, Inc.
900-000-016
In Commercial Distribution
- 00855728005031 ()
3032
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-017-053
In Commercial Distribution
- 00810098650199 ()
2580
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-017-005
In Commercial Distribution
- 00810098650175 ()
2580
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-017-003
In Commercial Distribution
- 00810098650083 ()
2580
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-017-0051
In Commercial Distribution
- 00810098650014 ()
2580
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: The central spherical zone, A mathematically designed sigmoidal corneal proximity “Return Zone” and A non-curving “Landing Zone”. Paragon CRT® Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The material is thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with blue, violet and green tints. The tinted lenses depending on the tint color contain D&C Green No. 6, D&C Violet No. 2 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated.
Paragon Vision Sciences, Inc.
Paragon CRT
In Commercial Distribution
- B22217 ()
- Orthokeratology contact lens
Paragon HDS® (paflufocon B) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in tinted versions. Paragon HDS® rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.
The Paragon HDS® rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers.
The Paragon HDS® rigid gas permeable tinted lenses offer color enhancement of the eye and a handling aid for locating the lens. These products may be plasma treated.
Paragon Vision Sciences, Inc.
Paragon HDS
In Commercial Distribution
- B22208 ()
- Orthokeratology contact lens
- Rigid-gas-permeable corrective contact lens, daily-wear
- Rigid-gas-permeable corrective contact lens, extended-wear
FluoroPerm® 60 (paflufocon B) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. FluoroPerm® 60 rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.
The FluoroPerm® 60 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers.
FluoroPerm® 60 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.
Paragon Vision Sciences, Inc.
Fluoroperm 60
In Commercial Distribution
- B22205 ()
- Rigid-gas-permeable corrective contact lens, daily-wear
- Rigid-gas-permeable corrective contact lens, extended-wear