Last synced on 27 January 2023 at 11:04 pm

Tens For Sinus Pain

Page Type
Product Code
Definition
Electrical stimulation to relieve pain
Physical State
Electrical stimulation unit with electrodes
Technical Method
Applies a transcutaneous electrical stimulation with electrodes on the skin.
Target Area
Sinuses around nose and forehead
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5890
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5890 Transcutaneous electrical nerve stimulator for pain relief

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a) Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

(b) Classification. Class II (performance standards).

Tens For Sinus Pain

Page Type
Product Code
Definition
Electrical stimulation to relieve pain
Physical State
Electrical stimulation unit with electrodes
Technical Method
Applies a transcutaneous electrical stimulation with electrodes on the skin.
Target Area
Sinuses around nose and forehead
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5890
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5890 Transcutaneous electrical nerve stimulator for pain relief

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a) Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

(b) Classification. Class II (performance standards).