PIR · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.4800
Classification
FDA Product Code
PIR
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 878.4800
Review panel
HO
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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).