Last synced on 12 April 2024 at 11:04 pm

External Mechanical Stimulator For The Relief Of Congestion

Page Type
Product Code
Definition
The external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion.
Physical State
The external mechanical stimulator consists of a transducer that delivers vibrations.
Technical Method
The external mechanical stimulator delivers resonant vibration through transducers
Target Area
Sinus and nasal areas of the face.
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.6010
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QZC is linked to regulation 21CFR874.6010, which does not seem to exist yet. It may be pending at the moment.

External Mechanical Stimulator For The Relief Of Congestion

Page Type
Product Code
Definition
The external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion.
Physical State
The external mechanical stimulator consists of a transducer that delivers vibrations.
Technical Method
The external mechanical stimulator delivers resonant vibration through transducers
Target Area
Sinus and nasal areas of the face.
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.6010
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QZC is linked to regulation 21CFR874.6010, which does not seem to exist yet. It may be pending at the moment.