Last synced on 4 February 2023 at 10:33 pm

Electrode, Needle, Diagnostic Electromyograph

Page Type
Product Code
Regulation Medical Specialty
Physical Medicine
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
890.1385
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 890.1385 Diagnostic electromyograph needle electrode

§ 890.1385 Diagnostic electromyograph needle electrode.

(a) Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).

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

Electrode, Needle, Diagnostic Electromyograph

Page Type
Product Code
Regulation Medical Specialty
Physical Medicine
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
890.1385
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 890.1385 Diagnostic electromyograph needle electrode

§ 890.1385 Diagnostic electromyograph needle electrode.

(a) Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).

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