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U.S. Department of Health and Human Services

Product Classification

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Device kit, first aid, talking
Regulation Description Nonresorbable gauze/sponge for external use.
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.
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 buttons. It is nothing more than an audio player, playing First Aid information as content.
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 Medical Specialty General & Plastic Surgery
Review Panel General Hospital
Product CodeOVR
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)
Regulation Number 878.4014
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible