Analyzer, Body Composition, Exempt
The Analyzer, Body Composition (Exempt) is a device used to measure and analyze body composition parameters such as fat mass, lean mass, and body water, typically through bioelectrical impedance analysis or similar techniques, to aid in nutritional assessment and clinical management. Product code PUH is the Class II exempt counterpart of MNW, exempted from the 510(k) requirement under the 21st Century Cures Act, subject to the limitations in 21 CFR 870.9. Under regulation 21 CFR 870.2770, it is a Class II device subject to general and special controls. It falls under the Cardiovascular medical specialty and is not flagged as an implant or life-sustaining device.
Basic Information
- Product Code
- PUH
- Device Class
- FDA class 2
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
Definition
This product code is the class II exempt counterpart of MNW, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
FEI Numbers
This FDA classification entry is associated with 64 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 64 registration numbers. Click on an entry to view related FDA registrations.