||fall prevention alarm/sensor attached only|
||This fall-prevention alarm/sensor works only when it is attached to a person.It attaches to a person usually by a clip or belt.
||This fall prevention alarm attaches to a person's body or clothing. A nurse call interface provides dual staff notification or enables the in-room alarm to be silenced.
||The alarm activates when the clip (alarm cord) disconnects from the alarm. This alarm may be connected to the Nurse Call System. If the alarm is connected to the hospital's Nurse Call System, the nurse call station signal activates. This device may also use an AC-power adaptor to power the alarm instead of batteries. The adaptor does not charge the batteries.
||The device can be used only when it is attached to the person. If attached to the person, it is attached to a person's clothing by use of the clip or it is worn around a person's waist with the supplied belt. It is not to be used on the head or neck areas. If the belt is used, the belt is applied around the person's waist. The belt is not looped around or through any chair, bed or furniture, so it does not act as a restraint.
|Regulation Medical Specialty
|| General Hospital
Office of Device Evaluation
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices
General Hospital Devices Branch (GHDB)
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.|
|If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
|Third Party Review
||Not Third Party Eligible