OAC · Plethysmograph, Air Displacement For Body Composition Analysis
Cardiovascular · 21 CFR 870.2770 · Class 2
Overview
| Product Code | OAC |
|---|---|
| Device Name | Plethysmograph, Air Displacement For Body Composition Analysis |
| Regulation | 21 CFR 870.2770 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
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.
Special Controls
*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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K060848 | BOD POD | Life Measurement, Inc. | Jun 27, 2006 | SESE |
| K032610 | MODIFIED SONAMET BODY COMPOSITION ANALYZER | Life Measurement, Inc. | Mar 1, 2004 | SESE |
| K924972 | SONAMET BODY COMPOSITION ANALYZER | Life Measurement Instruments, Inc. | Feb 13, 1995 | SESE |
Top Applicants
- Life Measurement, Inc. — 2 clearances
- Life Measurement Instruments, Inc. — 1 clearance
