FDA product code OVR: Kit, First Aid, Talking
OVR is the FDA product code for kit, first aid, talking. It is a Class I device, regulated under 21 CFR 878.4014 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under OVR. The average 510(k) review took 105 days (median 105).
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.
Classification
| Field | Value |
|---|---|
| Device name | Kit, First Aid, Talking |
| Device class | Class I |
| Regulation | 21 CFR 878.4014 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Top OVR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Safetymate, Inc. | 1 | 2011-06-17 |
Most recent OVR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K110625 | Safetymate, Inc. | SAFETYMATE TALKING FIRST AID | 2011-06-17 | 105 |
Recalls for OVR devices
openFDA lists no recalls for product code OVR.
Frequently asked questions
What is FDA product code OVR?
OVR is the FDA product code for kit, first aid, talking. It is a Class I device, regulated under 21 CFR 878.4014 and reviewed by the General Hospital panel.
What device class is OVR?
Class I, regulation 21 CFR 878.4014. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OVR?
Across 1 cleared submissions the average was 105 days from receipt to decision (median 105).
Which companies have the most OVR clearances?
Safetymate, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OVR
- Run a recall and safety report across every OVR manufacturer
- Watch product code OVR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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