FDA product code MHY: Stimulator, Electrical, Implanted, For Parkinsonian Tremor

MHY is the FDA product code for stimulator, electrical, implanted, for parkinsonian tremor. It is a Class III device, reviewed by the Neurology panel. Devices under MHY reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 46 recalls for MHY devices, 16 initiated in the last five years.

Classification

Recalls for MHY devices

46 product recalls in 35 recall events; 16 initiated in the last five years and 17 still open. Most recent: 2026-05-13.

Frequently asked questions

What is FDA product code MHY?

MHY is the FDA product code for stimulator, electrical, implanted, for parkinsonian tremor. It is a Class III device, reviewed by the Neurology panel.

What device class is MHY?

Class III. Typical premarket route: PMA.

Have MHY devices been recalled?

Yes: 46 product recalls across 35 recall events; the most recent began 2026-05-13.

Next steps

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