Last synced on 30 September 2022 at 11:05 pm

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Page Type
Product Code
Definition
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES
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, Nerve, Transcutaneous, Over-The-Counter

Page Type
Product Code
Definition
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES
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).