Search Results
Found 1 results
510(k) Data Aggregation
K Number
K121344Device Name
NU SLEEP
Manufacturer
Date Cleared
2012-10-17
(166 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
RH ASSOCIATES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nu Sleep appliance is indicated to treat mild to moderate Obstructive Sleep Apnea.
Device Description
Nu Sleep appliance is a patient specific made device for each patient which consists of two dental plates, upper and lower, made of Acrylic.
The attachment is at a 40 degree angle to enable movement of the appliances, thus patient can open and close while wearing the appliances. The appliance is open in the front and allowing the patient to inhale and exhale more air per breath.
The RH Associates obstructive sleep apnea appliance "Nu-Sleep" is offered in Hard/Soft which has a dual laminate layer that provides a soft layer on the tooth surface which is made of acrylic.
Ask a Question
Ask a specific question about this device
Page 1 of 1