Last synced on 14 June 2024 at 11:05 pm

Stimulator, Muscle, Powered, Dental

Page Type
Product Code
Definition
Relief of muscle spasms associated with tmj. Muscle reeducation, increasing blood flow.
Regulation Medical Specialty
Physical Medicine
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
890.5850
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 890.5850 Powered muscle stimulator

§ 890.5850 Powered muscle stimulator.

(a) Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

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

Stimulator, Muscle, Powered, Dental

Page Type
Product Code
Definition
Relief of muscle spasms associated with tmj. Muscle reeducation, increasing blood flow.
Regulation Medical Specialty
Physical Medicine
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
890.5850
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 890.5850 Powered muscle stimulator

§ 890.5850 Powered muscle stimulator.

(a) Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

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