FDA product code NYZ: Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning

NYZ is the FDA product code for stimulator, muscle, powered, with limited output, for muscle conditioning. It is a Class II device, regulated under 21 CFR 890.5850 and reviewed by the Physical Medicine panel. Devices under NYZ reach the market by 510(k); FDA lists no cleared 510(k)s for it.

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.

Classification

Recalls for NYZ devices

openFDA lists no recalls for product code NYZ.

Frequently asked questions

What is FDA product code NYZ?

NYZ is the FDA product code for stimulator, muscle, powered, with limited output, for muscle conditioning. It is a Class II device, regulated under 21 CFR 890.5850 and reviewed by the Physical Medicine panel.

What device class is NYZ?

Class II, regulation 21 CFR 890.5850. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code NYZ
• Run a recall and safety report across every NYZ manufacturer
• Watch product code NYZ for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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