| Device |
mercy tape 2d and 3d models |
| Regulation Description |
Manual surgical instrument for general use. |
| Definition |
The Mercy TAPE device (2D and 3D models) is intended for use by health care professionals to estimate the body weight of pediatric patients between the ages of 2 months and 16 years, using linear measurements from specific anatomical landmarks made with the TAPE device for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the mid-upper arm circumference (MUAC). |
| Physical State |
The Mercy TAPE device consists of semi-durable or disposable flexible strips of coated paper, fabric or plastic tape printed with numbered bins proportional to fractional body weight of pediatric patients. |
| Technical Method |
The 2D and 3D Mercy TAPE device combines the physical properties of the simple tape measure, with the intended use of the Stand-on patient scale and patient scale, which is estimation of body weight. TAPE performs this function based on an algorithm that is unique to the Mercy TAPE device. TAPE uses linear anthropometric body measurements to derive estimated body weight. |
| Target Area |
for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the mid-upper arm circumference (MUAC). |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General Hospital |
|---|
| Product Code | PIR |
|---|
| 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)
|
|---|
| Regulation Number |
878.4800
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
|
Third Party Review
|
Accredited Persons
|
