21 CFR 870.2770 — Plethysmograph, Impedance
Cardiovascular (CV) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2770
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DSB | Plethysmograph, Impedance | 2 | 114 | 3rd Party |
| MNW | Analyzer, Body Composition | 2 | 79 | |
| OAC | Plethysmograph, Air Displacement For Body Composition Analysis | 2 | 3 | 3rd Party |
| OBH | Monitor, Extracellular Fluid, Lymphedema, Extremity | 2 | 10 | |
| OMV | Ultrasonic Body Composition Analyzer | 2 | 1 | SaMD, 3rd Party |
| PUH | Analyzer, Body Composition, Exempt | 2 | 0 | |
| QAF | Impedance Plethysmograph, Cranial | 2 | 2 | |
| QJB | Adjunct Monitor, Protein Calorie Malnutrition | 2 | 2 |
Special Controls
DSB — Plethysmograph, Impedance
*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.
eCFR
MNW — Analyzer, Body Composition
*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.
eCFR
OAC — Plethysmograph, Air Displacement For Body Composition Analysis
*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.
eCFR
OBH — Monitor, Extracellular Fluid, Lymphedema, Extremity
*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.
eCFR
OMV — Ultrasonic Body Composition Analyzer
*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.
eCFR
PUH — Analyzer, Body Composition, Exempt
*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.
eCFR
QAF — Impedance Plethysmograph, Cranial
*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.
eCFR
QJB — Adjunct Monitor, Protein Calorie Malnutrition
*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.
eCFR
