Definition: Provides Real-time Feedback To The Rescuer Regarding The Quality Of CPR Being Delivered To The Victim, And Provides Either Audio And/or Visual Information To Encourage The Rescuer To Continue The Consistent Application Of Effective Manual CPR In Acco
| Device Type ID | 969 |
| Device Name | Cpr Aid Feedback Device (no Software) |
| Physical State | An External Device Generally Placed On Or Near The Subject/victim And Provides Audio And/or Visual Feedback To The Rescuer. |
| Technical Method | Mechanical Or Electro-mechanical. No Software. |
| Target Area | 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 2 Medical Device |
| Product Code | PMJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 969 |
| Device | Cpr Aid Feedback Device (no Software) |
| Product Code | PMJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Resuscitation (CPR) Aid. |
| CFR Regulation Number | 870.5210 [🔎] |