Last synced on 27 June 2025 at 11:06 pm

Stimulator, Muscle, Diagnostic

Page Type
Product Code
Regulation Medical Specialty
Physical Medicine
Review Panel
Physical Medicine
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
890.1850
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 890.1850 Diagnostic muscle stimulator

§ 890.1850 Diagnostic muscle stimulator.

(a) Identification. A diagnostic muscle stimulator is a device used mainly with an electromyograph machine to initiate muscle activity. It is intended for medical purposes, such as to diagnose motor nerve or sensory neuromuscular disorders and neuromuscular function.

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

Stimulator, Muscle, Diagnostic

Page Type
Product Code
Regulation Medical Specialty
Physical Medicine
Review Panel
Physical Medicine
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
890.1850
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 890.1850 Diagnostic muscle stimulator

§ 890.1850 Diagnostic muscle stimulator.

(a) Identification. A diagnostic muscle stimulator is a device used mainly with an electromyograph machine to initiate muscle activity. It is intended for medical purposes, such as to diagnose motor nerve or sensory neuromuscular disorders and neuromuscular function.

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