Anesthesiology
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- 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
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Monitor, Extracellular Fluid, Lymphedema, Extremity
- Page Type
- Product Code
- Definition
- Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with unilateral lymphedema (that is, in one affected extremity)
- 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
- Applies a small alternating current of one or more frequencies through electrodes attached to particular locations on the skin surface of the subject's body and then measures/calculates level of bioimpedance indicated by living tissue over the area assessed
- Target Area
- The arms and/or legs of the subject
- 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
- Eligible
- 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]