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Address: 6116 North Central Expressway, Suite 605, Dallas, Texas 75206, USA
amisleep.com |
Send Inquiry |
Phone: +1-(214)-691-3151
FDA Registration: 3003496134
Products: Non-Continuous Ventilator/Respirator (FDA Code:
BZD), Anti-Snoring Device (FDA Code:
LRK), ...
Airway Management, Inc. offers products that improve the health and quality of life for people who suffer from sleep-disordered breathing. The Thornton Adjustable Positioner® (TAP®) is an oral
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Address: 3537 Teasley Lane, Denton, Texas 76210, USA
www.somnomed.com |
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Phone: +1-(940)-381-5200
FDA Registration: 3005598536
Products: Seminar Service, Sleep Laboratory Services, Adjustable Positioners, Bruxism Devices, Conference Service, Anti-Snoring Device (FDA Code:
LRK), ...
Somnomed develops products for the treatment of sleeping disorders. Our SomnoMed MAS™ acrylic is made from acrylic that provides solution for snoring problems.
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Address: 5524 Cornish, Houston, Texas 77007-4304, USA
www.orthodontictechnologies.com |
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Phone: +1-(713)-861-0033, 800-346-5133
Products: Anti-Snoring Device (FDA Code:
LRK), ...
Orthodontic Technologies, Inc. specializes in offering dental device for snoring and sleep apnea. We provide various dental equipments and supplies.
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Address: 3 Hasadnaot St., Herzlia 46728, Israel
Phone: 972-9-951151
Products: Liquid Nitrogen Cryosurgical Units, Cryosurgical Unit (FDA Code:
GEH), Anti-Snoring Device (FDA Code:
LRK), ...
Influent Ltd. is a provider of bone screw system cryo surgical unit.
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Address: 18 Bayside Drive, Carrying Place, Ontario K0K 1L0, Canada
www.somnaform.com |
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Phone: +1-(416)-3236897
FDA Registration: 3013835136
Products: Snore Relief Throat Spray, Anti-Snoring Throat Sprays, Sleep Diagnostics, Snoring Sensors, Sleep Disorder Treatment Facilities, Disposable Medical Bed (FDA Code:
KME), Anti-Snoring Device (FDA Code:
LRK), ...
Somnaform Corporation produces medical devices and accessory products, which help clients to reduce chronic snoring, improve back supports or make CPAP/BIPAP use easier and more comfortable. Our syste
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FDA Code / Regulation: LRK / 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA."