| 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 Code | OVR |
|---|
| Premarket Review |
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
878.4014
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. |
| If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
