Definition: The Device Provides Verbal Instructions Pertaining To Various First Aid And Common Medical Emergencies. The Device Does Not Contain Any Drug Or Supporting Device That Could Be Applied To The Patient.
| Device Type ID | 2841 |
| Device Name | Kit, First Aid, Talking |
| Physical State | The Device Looks And Functions Like A Programmable Digital Audio Player, Playing Digital Audio Clips As Individual Digital Audio Files Containing Prerecorded, Spoken First Aid Information In A Prescribed Order (and Language) As User Pushes Specific B |
| Technical Method | The Device Works As An Audio Player Playing Various First Aid Instructions When Buttons Labeled With Those First Aid Emergencies Such As Choking, Burn Are Pressed. |
| Target Area | The Instructions Are Verbally Relayed To The User For Emergencies Pertaining To CPR, Unconscious, Choking, Breathing, Allergic Reaction, Bleeding, Burns, Falls, Bone Injury, Poison, Bites, Stings, Seizures. |
| Regulation Description | Nonresorbable Gauze/sponge For External Use. |
| Regulation Medical Specialty | General & Plastic Surgery |
| 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 | 878.4014 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OVR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2841 |
| Device | Kit, First Aid, Talking |
| Product Code | OVR |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nonresorbable Gauze/sponge For External Use. |
| CFR Regulation Number | 878.4014 [🔎] |