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Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes

Page Type
Product Code
Definition
Electrical stimulation for aesthetic purposes
Physical State
Electrical stimulation unit with leads and cutaneous electrodes
Technical Method
Electrical stimulation using current applied to electrodes on a patient's skin
Target Area
Electrodes are placed on the skin in proximity to the area of interest
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
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
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).

Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes

Page Type
Product Code
Definition
Electrical stimulation for aesthetic purposes
Physical State
Electrical stimulation unit with leads and cutaneous electrodes
Technical Method
Electrical stimulation using current applied to electrodes on a patient's skin
Target Area
Electrodes are placed on the skin in proximity to the area of interest
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
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
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).