PIR

Mercy Tape 2d And 3d Models

Product code

PIR

Device name

Mercy Tape 2d And 3d Models

Device class

Class 1

21 CFR

21 CFR 878.4800

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).