Mercy Tape 2d And 3d Models
The Mercy TAPE 2D and 3D Models are clinical measurement tools intended for use by healthcare professionals to estimate the body weight of pediatric patients between 2 months and 16 years of age using linear measurements from anatomical landmarks, including humeral length or half-humeral length and mid-upper arm circumference. They are FDA Class 1 devices regulated under 21 CFR 878.4800, subject to general controls, within the General and Plastic Surgery (SU) specialty. The product code is PIR, and the device is eligible for third-party review. These devices are not implants and are not life-sustaining.
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Basic Information
- Product Code
- PIR
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.