FDA product code NYZ

Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning

Physical Medicine·Class 2·21 CFR 890.5850
US regulatory classifications
US Product Code (FDA)
NYZ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 890.5850
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Medical specialty
Physical Medicine
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
Definition

Used for muscle stimulation for muscle conditioning. Device repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes and into the body. Temporarily affects the stimulated muscles contractile properties, force output, and/or fatigue resistance. Not intended to be used for medical purposes (e.g., rehabilitation), for aesthetic purposes (e.g., changing the physical appearance of the muscle or body), or for the purpose of improving athletic performance.

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About this record

Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning is a medical device type in the Physical Medicine specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.