Definition: A Device That Performs A Simple Function Such As Proper Hand Placement And/or Simple Prompting For Rate And/or Timing Of Compressions/breathing For The Professionally Trained Rescuer, But Offers No Feedback Related To The Quality Of The CPR Being Pro
| Device Type ID | 970 |
| Device Name | Cpr Aid Device Without Feedback |
| Physical State | External Device That Provides Audio And/or Visual Prompting Of Rate And/or Ventilation And/or Proper Placement Of Hands For CPR, In Accordance With Current CPR Guidelines. |
| Technical Method | Mechanical, Electro-mechanical, Software Can Be Included. Prompting Only - No Real-time Feedback Related To The CPR Being Performed. |
| Target Area | Near Rescuer (non Patient Contact) On Chest - Skin Contact. |
| Regulation Description | Cardiopulmonary Resuscitation (CPR) Aid. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 870.5210 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PMK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 970 |
| Device | Cpr Aid Device Without Feedback |
| Product Code | PMK |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Cardiopulmonary Resuscitation (CPR) Aid. |
| CFR Regulation Number | 870.5210 [🔎] |