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U.S. Department of Health and Human Services

Product Classification

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Device sleeve, head and neck, compressible
Regulation Description Compressible limb sleeve.
Definition Intended to move excess fluid from the target area to another area of the body.
Physical State The device consists of fabric garments, which may be filled with air chambers, that are designed to wrap around the head, face, and/or neck and apply compression. The garments may be attached to a controller, which manages inflation/deflation of air chambers to apply compression.
Technical Method Uses compression of the target area to move excess fluid to another area of the body
Target Area Head, face and/or neck
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePPS
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 870.5800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible