KeyNote
510(k) K863995
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK863995 | Date13 Nov 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ILQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3710
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The KeyNote is a System, Communication, Powered, classified as a Class II medical device under FDA regulations. It is designed as an auditory communication aid, facilitating hearing assessment and amplification for patients in physical medicine settings. The device operates by transmitting and modulating sound signals to support diagnostic and therapeutic evaluations of auditory function.
KeyNote is supplied as a reusable, non-sterile system intended for use in clinical environments such as physical medicine offices or audiometry labs. It requires proper calibration and maintenance to ensure accurate performance. The device is authorized under FDA 510(k) clearance (K863995) and adheres to regulatory standards outlined in 21 CFR 890.3710. No MRI safety or sterility requirements are specified, and its operation depends on electrical power and signal transmission components.
Other devices from Sensory Aids Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the KeyNote auditory communication system used for?
The KeyNote is designed as an auditory communication aid to facilitate hearing assessment and amplification during diagnostic and therapeutic evaluations in physical medicine settings. It transmits and modulates sound signals to help clinicians evaluate auditory function accurately, supporting both diagnostic testing and therapeutic interventions.
Is the KeyNote system reusable or single-use?
The KeyNote is supplied as a reusable system, meaning it is intended for repeated use in clinical environments like physical medicine offices or audiometry labs. Reusability requires proper calibration and maintenance to ensure consistent performance and accuracy over time.
Does the KeyNote system require sterilization?
No, the KeyNote is classified as a non-sterile device. Since it is intended for use in clinical settings where sterility is not a requirement for its function, it does not need to be sterilized before or after use. However, standard cleaning and maintenance procedures should still be followed to prevent contamination and ensure reliable operation.
What regulatory approval does the KeyNote system hold?
The KeyNote auditory communication system holds FDA 510(k) clearance under the reference number K863995. This clearance confirms that the device meets regulatory standards for safety and effectiveness as a Class II medical device under 21 CFR 890.3710, specifically for use in physical medicine settings.
How does the KeyNote system operate?
The KeyNote operates by transmitting and modulating sound signals, enabling clinicians to assess and amplify auditory function during evaluations. It relies on electrical power and signal transmission components to function effectively. Proper calibration is essential to ensure accurate performance, as the device is not intended for MRI environments and does not require MRI safety certifications.