Learn Mode Waterproof Pendant Panic Button
by Interactive Technologies, Inc.
510(k) K940223
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK940223 | Date29 Apr 1994 | 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- Withdrawn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
- IQA
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3725
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Learn Mode Waterproof Pendant Panic Button is a System, Environmental Control, Powered device designed for emergency response. It functions as a wearable panic alarm that transmits signals to a central monitoring system when activated, enabling rapid assistance in medical or security emergencies. The device is intended for use in environments where immediate communication is critical, such as healthcare facilities or residential settings.
This device is supplied as a single-use or reusable component, depending on manufacturer specifications, and is intended for non-sterile use. It is waterproof and can be worn as a pendant, ensuring functionality in wet conditions. The Learn Mode feature allows for programming and customization of the device’s response parameters. Authorized under FDA 510(k) clearance (K940223), it adheres to regulatory standards for physical medicine applications and is classified as a Class II medical device.
Questions
AI-generated answers, 1 Oct 2026
What is the Learn Mode Waterproof Pendant Panic Button used for?
The Learn Mode Waterproof Pendant Panic Button is designed as a wearable panic alarm for emergency response. It transmits signals to a central monitoring system when activated, enabling immediate assistance in critical situations such as medical or security emergencies. The device is particularly suited for environments where quick communication is essential, like healthcare facilities or residential areas.
Is the Learn Mode Waterproof Pendant Panic Button reusable or single-use?
The Learn Mode Waterproof Pendant Panic Button can be supplied either as a single-use or reusable component, depending on the specific manufacturer’s specifications. This flexibility allows users to choose based on their operational needs and usage frequency.
Can the device be used in wet conditions?
Yes, the Learn Mode Waterproof Pendant Panic Button is explicitly designed to be waterproof, ensuring reliable functionality even when worn in wet environments. This feature makes it ideal for use in situations where exposure to moisture is likely.
How does the Learn Mode feature work?
The Learn Mode feature allows users to program and customize the device’s response parameters. This means the panic button can be tailored to specific emergency protocols, ensuring that the transmitted signals align with the user’s or facility’s predefined requirements for rapid assistance.
What regulatory status does this device hold?
The Learn Mode Waterproof Pendant Panic Button holds FDA 510(k) clearance under the reference number K940223. It is classified as a Class II medical device and adheres to regulatory standards for physical medicine applications, ensuring compliance with relevant safety and performance guidelines.