| Device |
fall prevention alarm/sensor attached only |
| Regulation Description |
Bed-patient monitor. |
| Definition |
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 . |
| Physical State |
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. |
| Technical Method |
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. |
| Target Area |
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 |
| Review Panel |
General Hospital |
|---|
| Product Code | PJP |
|---|
| 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 |
