| Device |
fall prevention alarm/sensor combination attached or unattached |
| Regulation Description |
Bed-patient monitor. |
| Definition |
The fall-prevention alarm/sensor is a combination device that can attach to a person usually by a clip or belt OR it can be used unattached to the person, where the person sits upon it. |
| Physical State |
This fall prevention alarm can be used two way. It can attach to a person's body or clothing or it can be used unattached where the person sits upon the sensor pad as with devices cleared under product code KMI. |
| Technical Method |
The alarm activates when weight is applied to the sensor changes or the magnet clip 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. |
| Target Area |
Device can be used two different ways: 1) attached to the person or 2) not attached to the person. If used attached to the person, it can be applied to a person's clothing by use of the clip or it is worn around a person's waist via the belt. It is not to be used on the head or neck areas. If the belt is used, only the belt is applied around the person's waist. The belt is not looped around or through any chair, bed or furnituOrre so it does not act as a restraint. If the device not not attached, the patient sits or lies upon the sensor pad. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | PJO |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
880.2400
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| 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. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
