Last synced on 2 December 2022 at 11:04 pm

Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion

Page Type
Product Code
Definition
A transcutaneous electrical nerve stimulator for the relief of congestion is a device that electrically stimulates the skin overlying the paranasal sinuses to relieve congestion.
Physical State
This device is for external application and includes an active and return electrode, battery, and software.
Technical Method
This device is an electrical stimulator and applies a low level of electrical current to the skin overlying the paranasal sinuses.
Target Area
The skin overlying the paranasal sinuses
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.6000
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 QNU is linked to regulation 21CFR874.6000, which does not seem to exist yet. It may be pending at the moment.

Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion

Page Type
Product Code
Definition
A transcutaneous electrical nerve stimulator for the relief of congestion is a device that electrically stimulates the skin overlying the paranasal sinuses to relieve congestion.
Physical State
This device is for external application and includes an active and return electrode, battery, and software.
Technical Method
This device is an electrical stimulator and applies a low level of electrical current to the skin overlying the paranasal sinuses.
Target Area
The skin overlying the paranasal sinuses
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.6000
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 QNU is linked to regulation 21CFR874.6000, which does not seem to exist yet. It may be pending at the moment.