Transducer for Kontrol 5MHZ Sigma 20

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K843355 ↗

FDA Product Code

MHZ

Device Class

Class III

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

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See all devices from Kontron Instruments, Inc. →

• What clinical applications is this transducer designed for, and how does it work?

  This transducer is part of the Kontrol system and is specifically designed to deliver controlled mechanical vestibular stimulation at 5 MHz for therapeutic or assessment purposes. It applies precise acceleration stimuli to the vestibular system, which can help evaluate or treat vestibular function—commonly used in research or clinical settings for conditions affecting balance or inner ear function.

• Is this transducer single-use or reusable, and what maintenance is required?

  The transducer is reusable and intended for repeated use in clinical or research environments. Since it is not sterile out-of-box, it must be sterilized and maintained according to the manufacturer’s guidelines to ensure safety and performance. Proper cleaning and sterilization protocols are critical before each use to prevent contamination.

• What regulatory pathway was followed for this device, and when was it cleared?

  This device received a Traditional 510(k) clearance from the FDA in December 1984 under the classification of a Class III device. The clearance (K843355) was granted based on a determination of substantial equivalence to a predicate device, meaning it was evaluated for safety and effectiveness in its intended use.

• How is this transducer supplied, and what system compatibility does it require?

  The transducer is supplied as a standalone reusable component and is integrated with the Kontrol system for operation. It is not sold independently but must be used in conjunction with the Kontrol platform to deliver the specified 5 MHz vestibular acceleration stimulation. Compatibility with the Kontrol system is mandatory for proper functionality.