Kit, First Aid, Talking
The Kit, First Aid, Talking (product code OVR) is a device that provides verbal audio instructions pertaining to various first aid and common medical emergencies to guide users through emergency response procedures. The device does not contain any drugs or supporting devices that could be applied to the patient; it serves purely as an instructional tool. As an FDA Class 1 device under regulation 878.4014, it is subject only to general controls and falls within the General and Plastic Surgery specialty, reviewed by the General Hospital panel. The device is not an implant and is not life-sustaining.
Research product code OVR in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OVR
- Device Class
- FDA class 1
- Regulation Number
- 878.4014
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K110625 | SAFETYMATE TALKING FIRST AID | Jun 17, 2011 | Substantially Equivalent | Safetymate, Inc. |
FEI Numbers
This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.