PIR — Mercy Tape 2d And 3d Models Class I
FDA product code PIR covers "Mercy Tape 2d And 3d Models", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PIR
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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).