Anesthesiology
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- Subpart G—Miscellaneous DevicesCFR Sub-Part
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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
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
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).