Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Adjunct Monitor, Protein Calorie Malnutrition
- Page Type
- Product Code
- Definition
- Device applies an alternating current of one specified frequency or more through skin-surface electrodes to estimate one or more the body composition parameters.
- Physical State
- Electronic black box/monitor with keypad or other interface and display having the ability to connect to four electrodes and computer.
- Technical Method
- Applying a small electrical alternating current of one or more frequencies to living tissue, the device measures current (I), voltage (V) and phase angle (Phi) response, and from these values, calculates resistance (R), reactance (Xc), and impedance (Z), which are used to further calculate estimated body composition parameters via empirical algorithms.
- Target Area
- Although the device is connected at different locations of the subject’s skin such as the palms of each hand and the soles of each foot, the signal is distributed through the entire body.
- Regulation Medical Specialty
- Cardiovascular
- Review Panel
- Gastroenterology and Urology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 870.2770
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 870.2770 Impedance plethysmograph
§ 870.2770 Impedance plethysmograph.
(a) Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.
(b) Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]