FDA product code NYY: Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation

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

Definition

Used for muscle stimulation for rehabilitation. Device repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes contacting the affected body area. Indicated for use as an adjunctive therapy in rehabilitation for medical purposes such as relaxation of muscle spasm, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Classification

Recalls for NYY devices

openFDA lists no recalls for product code NYY.

Frequently asked questions

What is FDA product code NYY?

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

What device class is NYY?

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 NYY
• Run a recall and safety report across every NYY manufacturer
• Watch product code NYY 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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