Last synced on 27 January 2023 at 11:04 pm

Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

Page Type
Product Code
Definition
Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.
Physical State
plastic with adhesive; valve that changes position with inspiration/expiration to provide decreased/increased resistance
Technical Method
intranasal device that creates expiratory resistance
Target Area
inserted into nares of nose to maintain upper airway pressure.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.5570
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a) Identification. 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.

(b) 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.”

[67 FR 68512, Nov. 12, 2002]

Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

Page Type
Product Code
Definition
Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.
Physical State
plastic with adhesive; valve that changes position with inspiration/expiration to provide decreased/increased resistance
Technical Method
intranasal device that creates expiratory resistance
Target Area
inserted into nares of nose to maintain upper airway pressure.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.5570
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a) Identification. 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.

(b) 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.”

[67 FR 68512, Nov. 12, 2002]