FDA product code MHZ: Stimulator, Vestibular Acceleration, Therapeutic

MHZ is the FDA product code for stimulator, vestibular acceleration, therapeutic. It is a Class III device, reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under MHZ. The average 510(k) review took 98 days (median 98). FDA has posted 2 recalls for MHZ devices.

Classification

Compare with all 510(k) review times · Search every MHZ clearance

Top MHZ applicants

Most recent MHZ clearances

Recalls for MHZ devices

2 product recalls in 2 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2018-08-31.

Frequently asked questions

What is FDA product code MHZ?

MHZ is the FDA product code for stimulator, vestibular acceleration, therapeutic. It is a Class III device, reviewed by the Neurology panel.

What device class is MHZ?

Class III. Typical premarket route: Contact FDA.

How long does a 510(k) take for product code MHZ?

Across 1 cleared submissions the average was 98 days from receipt to decision (median 98).

Which companies have the most MHZ clearances?

Kontron Instruments, Inc. (1).

Have MHZ devices been recalled?

Yes: 2 product recalls across 2 recall events; the most recent began 2018-08-31.

Next steps

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