| Device |
pediatric position holder |
| Regulation Description |
Pediatric position holder. |
| Definition |
Device used to physically restrain a pediatric patient for a short surgical or clinical procedure such as circumcision. Not intended for prolonged positioning. |
| Physical State |
Made of non-permeable and non-porous material |
| Technical Method |
The pediatric position holder is a device made of non-permeable and non-porous material and molded with smooth edges for single patient use or multi-patient reuse. Holders that use disposable straps are used to hold an infant or a child in an anatomically correct position during short medical procedures such as circumcision. The holder is used only under constant supervision of a medical professional in a health care facility and is for prescription use only. |
| Target Area |
Pediatrics |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | PRN |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
880.5680
|
|---|
| 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 |
