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 .
| Device Type ID | 2745 |
| Device Name | Fall Prevention Alarm/sensor Attached Only |
| 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 A |
| 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 |
| Regulation Description | Bed-patient Monitor. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.2400 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PJP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2745 |
| Device | Fall Prevention Alarm/sensor Attached Only |
| Product Code | PJP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Bed-patient Monitor. |
| CFR Regulation Number | 880.2400 [🔎] |
| Device Problems | |
|---|---|
Communication Or Transmission Problem | 3 |
No Audible Alarm | 1 |
Mechanical Problem | 1 |
| Total Device Problems | 5 |