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U.S. Department of Health and Human Services

Product Classification

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Device antimicrobial blood pressure cuff
Regulation Description Blood pressure cuff.
Definition Device is a replacement cuff to be used in conjunction with a non-invasive blood pressure monitor. Together the devices determine blood pressures and heart rate. This particular cuff contains an embedded antimicrobial. A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Physical State The device is a typically a textile enfolded over an inflatable bladder.
Technical Method The blood pressure cuff wraps around the subject's arm or wrist and the bladder is inflated. The pressure from the bladder occludes the artery. When the pressure is slowly released, the Korotkoff sounds or oscillometric wave form produced is interpreted as sytolic and diastolic blood pressures.
Target Area The cuff is placed either over the upper arm, wrist, or thigh.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeOED
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.1120
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
Accredited Persons